Clinical Phase III Product Report

Clinical Phase III Product Report
Author: Philippe Tramoy
Date: 20 September 2010
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prohibited. The information herein was obtained from various sources; we do not guarantee its accuracy or completeness.
This research report is prepared for general circulation and is circulated for general information only. It does not have
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Table of Content
1) (R)-FLURBIPROFEN .................................................................................................................. 102
Summary ......................................................................................................................................... 102

Originators ....................................................................................................................................... 102
Licensing and General info: ............................................................................................................. 102
Clinical Data: .................................................................................................................................... 102
2) 13-CIS-RETINOIC ACID ............................................................................................................. 104
Summary ......................................................................................................................................... 104

Originators ....................................................................................................................................... 104
Clinical Data: .................................................................................................................................... 105
3) 166HO-PHYTATE ...................................................................................................................... 107
Summary ......................................................................................................................................... 107

Originators ....................................................................................................................................... 107
Clinical Data: .................................................................................................................................... 107
4) 2-PX.......................................................................................................................................... 109
Summary ......................................................................................................................................... 109

Originators ....................................................................................................................................... 109
Clinical Data: .................................................................................................................................... 110
5) AB-1001 ................................................................................................................................... 112
Summary ......................................................................................................................................... 112

Originators ....................................................................................................................................... 112
Clinical Data: .................................................................................................................................... 112
6) ABIRATERONE ACETATE .......................................................................................................... 114
Summary ......................................................................................................................................... 114
CBDM.T® - Market & Business Intelligence © 2010 1/1749

Originators ....................................................................................................................................... 114
Clinical Data: .................................................................................................................................... 114
7) ACADESINE .............................................................................................................................. 116
Summary ......................................................................................................................................... 117

Originators ....................................................................................................................................... 117
Clinical Data: .................................................................................................................................... 117
8) ACETAMINOPHEN + TRAMADOL HYDROCHLORIDE ................................................................ 119
Summary ......................................................................................................................................... 119

Originators ....................................................................................................................................... 119
Clinical Data: .................................................................................................................................... 119
9) ACETYLCHOLINESTERASE INHIBITOR (PFIZER) ........................................................................ 121
Summary ......................................................................................................................................... 121

Originators ....................................................................................................................................... 122
Clinical Data: .................................................................................................................................... 122
10) ACOTIAMIDE ............................................................................................................................ 124
Summary ......................................................................................................................................... 124

Originators ....................................................................................................................................... 124
Clinical Data: .................................................................................................................................... 124
11) ACTELION-1 ............................................................................................................................. 126
Summary ......................................................................................................................................... 126

Originators ....................................................................................................................................... 127
Clinical Data: .................................................................................................................................... 127
12) ACTIMMUNE............................................................................................................................ 129
Summary ......................................................................................................................................... 129

Originators ....................................................................................................................................... 129

Clinical Data: .................................................................................................................................... 129
13) ACYCLOVIR............................................................................................................................... 131
Summary ......................................................................................................................................... 131

Originators ....................................................................................................................................... 132
Clinical Data: .................................................................................................................................... 132
14) AD-923 ..................................................................................................................................... 134
Summary ......................................................................................................................................... 134

Originators ....................................................................................................................................... 134
Clinical Data: .................................................................................................................................... 134
15) ADENOVIRUS TYPES 4 AND 7 LIVE ORAL VACCINES ................................................................ 136
Summary ......................................................................................................................................... 136

Originators ....................................................................................................................................... 136
Clinical Data: .................................................................................................................................... 137
16) ADI-PEG-20 .............................................................................................................................. 139
Summary ......................................................................................................................................... 139

Originators ....................................................................................................................................... 139
Clinical Data: .................................................................................................................................... 139
17) ADLEA ...................................................................................................................................... 141
Summary ......................................................................................................................................... 141

Originators ....................................................................................................................................... 141
Clinical Data: .................................................................................................................................... 141
18) ADRENOCHROME MONOSEMICARBAZONE............................................................................ 143
Summary ......................................................................................................................................... 144

Originators ....................................................................................................................................... 144
Clinical Data: .................................................................................................................................... 144
19) ADS-5101 ................................................................................................................................. 146

Summary ......................................................................................................................................... 146
Originators ....................................................................................................................................... 146
Clinical Data: .................................................................................................................................... 146
20) ADULT MYOGENIC STEM CELL THERAPY ................................................................................. 148
Summary ......................................................................................................................................... 149

Originators ....................................................................................................................................... 149
Clinical Data: .................................................................................................................................... 149
21) AERUGEN ................................................................................................................................. 151
Summary ......................................................................................................................................... 151

Originators ....................................................................................................................................... 151
Clinical Data: .................................................................................................................................... 151
22) AFAMELANOTIDE..................................................................................................................... 153
Summary ......................................................................................................................................... 154

Originators ....................................................................................................................................... 154
Clinical Data: .................................................................................................................................... 154
23) AGOMELATINE......................................................................................................................... 156
Summary ......................................................................................................................................... 156

Originators ....................................................................................................................................... 156
Clinical Data: .................................................................................................................................... 156
24) AIDSVAX ................................................................................................................................... 158
Summary ......................................................................................................................................... 159

Originators ....................................................................................................................................... 159
Clinical Data: .................................................................................................................................... 159
25) AK-120 ..................................................................................................................................... 161
Summary ......................................................................................................................................... 161

Originators ....................................................................................................................................... 161

Clinical Data: .................................................................................................................................... 161
26) ALBIGLUTIDE............................................................................................................................ 163
Summary ......................................................................................................................................... 164

Originators ....................................................................................................................................... 164
Clinical Data: .................................................................................................................................... 164
27) ALENDRONATE (EFFERVESCENT) ............................................................................................. 166
Summary ......................................................................................................................................... 166

Originators ....................................................................................................................................... 166
Clinical Data: .................................................................................................................................... 166
28) ALFERMINOGENE TADENOVEC ............................................................................................... 168
Summary ......................................................................................................................................... 169

Originators ....................................................................................................................................... 169
Clinical Data: .................................................................................................................................... 169
29) ALISTA ...................................................................................................................................... 171
Summary ......................................................................................................................................... 171

Originators ....................................................................................................................................... 171
Clinical Data: .................................................................................................................................... 171
30) ALLOVECTIN-7.......................................................................................................................... 173
Summary ......................................................................................................................................... 174

Originators ....................................................................................................................................... 174
Clinical Data: .................................................................................................................................... 174
31) ALMOREXANT .......................................................................................................................... 176
Summary ......................................................................................................................................... 176

Originators ....................................................................................................................................... 176
Clinical Data: .................................................................................................................................... 176

32) ALPHA-1 ANTITRYPSIN (KAMADA) .......................................................................................... 178
Summary ......................................................................................................................................... 179

Originators ....................................................................................................................................... 179
Clinical Data: .................................................................................................................................... 179
33) ALPROSTADIL + PRAZOSIN....................................................................................................... 181
Summary ......................................................................................................................................... 181

Originators ....................................................................................................................................... 181
Clinical Data: .................................................................................................................................... 181
34) ALS-02 ...................................................................................................................................... 183
Summary ......................................................................................................................................... 184

Originators ....................................................................................................................................... 184
Clinical Data: .................................................................................................................................... 184
35) ALTROPANE ............................................................................................................................. 186
Summary ......................................................................................................................................... 186

Originators ....................................................................................................................................... 186
Clinical Data: .................................................................................................................................... 186
36) ALVAC ...................................................................................................................................... 188
Summary ......................................................................................................................................... 189

Originators ....................................................................................................................................... 189
Clinical Data: .................................................................................................................................... 189
37) ALVOCIDIB ............................................................................................................................... 191
Summary ......................................................................................................................................... 191

Originators ....................................................................................................................................... 191
Clinical Data: .................................................................................................................................... 191
38) AMBISOME .............................................................................................................................. 193
Summary ......................................................................................................................................... 194

Originators ....................................................................................................................................... 194
Clinical Data: .................................................................................................................................... 194
39) AMBRISENTAN......................................................................................................................... 196
Summary ......................................................................................................................................... 196

Originators ....................................................................................................................................... 196
Clinical Data: .................................................................................................................................... 196
40) AMEDIPLASE ............................................................................................................................ 198
Summary ......................................................................................................................................... 199

Originators ....................................................................................................................................... 199
Clinical Data: .................................................................................................................................... 199
41) AMINOCAPROIC ACID .............................................................................................................. 201
Summary ......................................................................................................................................... 201

Originators ....................................................................................................................................... 201
Clinical Data: .................................................................................................................................... 201
42) AMONAFIDE MALATE .............................................................................................................. 203
Summary ......................................................................................................................................... 204

Originators ....................................................................................................................................... 204
Clinical Data: .................................................................................................................................... 204
43) AMRUBICIN.............................................................................................................................. 206
Summary ......................................................................................................................................... 206

Originators ....................................................................................................................................... 206
Clinical Data: .................................................................................................................................... 206
44) AMT-011 .................................................................................................................................. 208
Summary ......................................................................................................................................... 209

Originators ....................................................................................................................................... 209

Clinical Data: .................................................................................................................................... 209
45) AN-072 ..................................................................................................................................... 211
Summary ......................................................................................................................................... 211

Originators ....................................................................................................................................... 211
Clinical Data: .................................................................................................................................... 211
46) ANDROGEN .............................................................................................................................. 213
Summary ......................................................................................................................................... 214

Originators ....................................................................................................................................... 214
Clinical Data: .................................................................................................................................... 214
47) ANX-510 ................................................................................................................................... 216
Summary ......................................................................................................................................... 216

Originators ....................................................................................................................................... 216
Clinical Data: .................................................................................................................................... 216
48) ANYARA ................................................................................................................................... 218
Summary ......................................................................................................................................... 219

Originators ....................................................................................................................................... 219
Clinical Data: .................................................................................................................................... 219
49) APADENOSON.......................................................................................................................... 221
Summary ......................................................................................................................................... 221

Originators ....................................................................................................................................... 221
Clinical Data: .................................................................................................................................... 221
50) APAZIQUONE ........................................................................................................................... 223
Summary ......................................................................................................................................... 224

Originators ....................................................................................................................................... 224
Clinical Data: .................................................................................................................................... 224
51) APIXABAN ................................................................................................................................ 226

Summary ......................................................................................................................................... 226
Originators ....................................................................................................................................... 226
Clinical Data: .................................................................................................................................... 226
52) APL-202.................................................................................................................................... 228
Summary ......................................................................................................................................... 229

Originators ....................................................................................................................................... 229
Clinical Data: .................................................................................................................................... 229
53) APLIGRAF ................................................................................................................................. 231
Summary ......................................................................................................................................... 231

Originators ....................................................................................................................................... 231
Clinical Data: .................................................................................................................................... 231
54) ARENEGYR ............................................................................................................................... 233
Summary ......................................................................................................................................... 234

Originators ....................................................................................................................................... 234
Clinical Data: .................................................................................................................................... 234
55) ARGATROBAN .......................................................................................................................... 236
Summary ......................................................................................................................................... 236

Originators ....................................................................................................................................... 236
Clinical Data: .................................................................................................................................... 236
56) ARILVAX ................................................................................................................................... 238
Summary ......................................................................................................................................... 239

Originators ....................................................................................................................................... 239
Clinical Data: .................................................................................................................................... 239
57) AROFYLLINE ............................................................................................................................. 241
Summary ......................................................................................................................................... 241

Originators ....................................................................................................................................... 241

Clinical Data: .................................................................................................................................... 241
58) ART-123 ................................................................................................................................... 243
Summary ......................................................................................................................................... 244

Originators ....................................................................................................................................... 244
Clinical Data: .................................................................................................................................... 244
59) ARTEMETHER + LUMEFANTRINE ............................................................................................. 246
Summary ......................................................................................................................................... 246

Originators ....................................................................................................................................... 246
Clinical Data: .................................................................................................................................... 246
60) ARVERAPAMIL ......................................................................................................................... 248
Summary ......................................................................................................................................... 249

Originators ....................................................................................................................................... 249
Clinical Data: .................................................................................................................................... 249
61) ARZOXIFENE............................................................................................................................. 251
Summary ......................................................................................................................................... 251

Originators ....................................................................................................................................... 251
Clinical Data: .................................................................................................................................... 251
62) ASA-404 ................................................................................................................................... 253
Summary ......................................................................................................................................... 254

Originators ....................................................................................................................................... 254
Clinical Data: .................................................................................................................................... 254
63) ASF-1057.................................................................................................................................. 256
Summary ......................................................................................................................................... 256

Originators ....................................................................................................................................... 256
Clinical Data: .................................................................................................................................... 256

64) ASIMADOLINE .......................................................................................................................... 258
Summary ......................................................................................................................................... 259

Originators ....................................................................................................................................... 259
Clinical Data: .................................................................................................................................... 259
65) ASOPRISNIL .............................................................................................................................. 261
Summary ......................................................................................................................................... 261

Originators ....................................................................................................................................... 261
Clinical Data: .................................................................................................................................... 261
66) AST-726.................................................................................................................................... 263
Summary ......................................................................................................................................... 264

Originators ....................................................................................................................................... 264
Clinical Data: .................................................................................................................................... 264
67) ATALUREN ............................................................................................................................... 266
Summary ......................................................................................................................................... 266

Originators ....................................................................................................................................... 266
Clinical Data: .................................................................................................................................... 267
68) ATAMESTANE .......................................................................................................................... 269
Summary ......................................................................................................................................... 269

Originators ....................................................................................................................................... 269
Clinical Data: .................................................................................................................................... 269
69) ATI-BC-1 ................................................................................................................................... 271
Summary ......................................................................................................................................... 271

Originators ....................................................................................................................................... 271
Clinical Data: .................................................................................................................................... 272
70) AV-45 ....................................................................................................................................... 274
Summary ......................................................................................................................................... 274

Originators ....................................................................................................................................... 274
Clinical Data: .................................................................................................................................... 274
71) AVANAFIL ................................................................................................................................. 276
Summary ......................................................................................................................................... 276

Originators ....................................................................................................................................... 277
Clinical Data: .................................................................................................................................... 277
72) AVE-5026 ................................................................................................................................. 279
Summary ......................................................................................................................................... 279

Originators ....................................................................................................................................... 279
Clinical Data: .................................................................................................................................... 279
73) AVE-8062 ................................................................................................................................. 281
Summary ......................................................................................................................................... 281

Originators ....................................................................................................................................... 282
Clinical Data: .................................................................................................................................... 282
74) AVIAN INFLUENZA VACCINE .................................................................................................... 284
Summary ......................................................................................................................................... 284

Originators ....................................................................................................................................... 284
Clinical Data: .................................................................................................................................... 284
75) AVIPTADIL ................................................................................................................................ 286
Summary ......................................................................................................................................... 287

Originators ....................................................................................................................................... 287
Clinical Data: .................................................................................................................................... 287
76) AVIPTADIL + PHENTOLAMINE MESYLATE ................................................................................ 289
Summary ......................................................................................................................................... 289

Originators ....................................................................................................................................... 289

Clinical Data: .................................................................................................................................... 289
77) AXITINIB ................................................................................................................................... 291
Summary ......................................................................................................................................... 292

Originators ....................................................................................................................................... 292
Clinical Data: .................................................................................................................................... 292
78) AZIMILIDE ................................................................................................................................ 294
Summary ......................................................................................................................................... 294

Originators ....................................................................................................................................... 294
Clinical Data: .................................................................................................................................... 294
81) AZITHROMYCIN + ANTI-INFLAMMATORY STEROID................................................................. 297
Summary ......................................................................................................................................... 297

Originators ....................................................................................................................................... 297
Clinical Data: .................................................................................................................................... 297
82) BACLOFEN ER........................................................................................................................... 299
Summary ......................................................................................................................................... 299

Originators ....................................................................................................................................... 300
Clinical Data: .................................................................................................................................... 300
83) BALAGLITAZONE ...................................................................................................................... 302
Summary ......................................................................................................................................... 302

Originators ....................................................................................................................................... 302
Clinical Data: .................................................................................................................................... 302
84) BAPINEUZUMAB ...................................................................................................................... 304
Summary ......................................................................................................................................... 304

Originators ....................................................................................................................................... 305
Clinical Data: .................................................................................................................................... 305
85) BAZEDOXIFENE + CONJUGATED ESTROGENS .......................................................................... 307

Summary ......................................................................................................................................... 307
Originators ....................................................................................................................................... 307
Clinical Data: .................................................................................................................................... 307
86) BCI-540 .................................................................................................................................... 309
Summary ......................................................................................................................................... 310

Originators ....................................................................................................................................... 310
Clinical Data: .................................................................................................................................... 310
87) BECLOMETHASONE DIPROPIONATE........................................................................................ 312
Summary ......................................................................................................................................... 312

Originators ....................................................................................................................................... 312
Clinical Data: .................................................................................................................................... 312
88) BELAGENPUMATUCEL-L .......................................................................................................... 314
Summary ......................................................................................................................................... 315

Originators ....................................................................................................................................... 315
Clinical Data: .................................................................................................................................... 315
89) BENEFIN ................................................................................................................................... 317
Summary ......................................................................................................................................... 317

Originators ....................................................................................................................................... 317
Clinical Data: .................................................................................................................................... 318
90) BEPOTASTINE BESILATE ........................................................................................................... 320
Summary ......................................................................................................................................... 320

Originators ....................................................................................................................................... 320
Clinical Data: .................................................................................................................................... 320
91) BEVASIRANIB SODIUM ............................................................................................................ 322
Summary ......................................................................................................................................... 322

Originators ....................................................................................................................................... 322

Clinical Data: .................................................................................................................................... 323
92) BG-9928 ................................................................................................................................... 325
Summary ......................................................................................................................................... 325

Originators ....................................................................................................................................... 325
Clinical Data: .................................................................................................................................... 325
93) BIBW-2992 ............................................................................................................................... 327
Summary ......................................................................................................................................... 327

Originators ....................................................................................................................................... 328
Clinical Data: .................................................................................................................................... 328
94) BICIFADINE .............................................................................................................................. 330
Summary ......................................................................................................................................... 330

Originators ....................................................................................................................................... 330
Clinical Data: .................................................................................................................................... 330
95) BILASTINE ................................................................................................................................ 332
Summary ......................................................................................................................................... 332

Originators ....................................................................................................................................... 333
Clinical Data: .................................................................................................................................... 333
96) BILAYERED CELLULAR MATRIX................................................................................................. 335
Summary ......................................................................................................................................... 335

Originators ....................................................................................................................................... 335
Clinical Data: .................................................................................................................................... 335
97) BINODENOSON ........................................................................................................................ 337
Summary ......................................................................................................................................... 338

Originators ....................................................................................................................................... 338
Clinical Data: .................................................................................................................................... 338

98) BIOVAXID ................................................................................................................................. 340
Summary ......................................................................................................................................... 340

Originators ....................................................................................................................................... 340
Clinical Data: .................................................................................................................................... 340
99) BLEOMYCIN SULFATE .............................................................................................................. 342
Summary ......................................................................................................................................... 343

Originators ....................................................................................................................................... 343
Clinical Data: .................................................................................................................................... 343
100) BLONANSERIN ......................................................................................................................... 345
Summary ......................................................................................................................................... 345

Originators ....................................................................................................................................... 345
Clinical Data: .................................................................................................................................... 346
101) BLP-25 LIPOSOME VACCINE .................................................................................................... 348
Summary ......................................................................................................................................... 348

Originators ....................................................................................................................................... 348
Clinical Data: .................................................................................................................................... 348
102) BNP-1350 ................................................................................................................................. 350
Summary ......................................................................................................................................... 350

Originators ....................................................................................................................................... 350
Clinical Data: .................................................................................................................................... 351
103) BNP-7787 ................................................................................................................................. 353
Summary ......................................................................................................................................... 353

Originators ....................................................................................................................................... 353
Clinical Data: .................................................................................................................................... 353
104) BOTULINUM TOXIN TYPE A ..................................................................................................... 355
Summary ......................................................................................................................................... 355

Originators ....................................................................................................................................... 356
Clinical Data: .................................................................................................................................... 356
105) BRENTUXIMAB VEDOTIN ......................................................................................................... 358
Summary ......................................................................................................................................... 358

Originators ....................................................................................................................................... 358
Clinical Data: .................................................................................................................................... 358
106) BRIVARACETAM ....................................................................................................................... 360
Summary ......................................................................................................................................... 360

Originators ....................................................................................................................................... 361
Clinical Data: .................................................................................................................................... 361
107) BSI-201..................................................................................................................................... 363
Summary ......................................................................................................................................... 363

Originators ....................................................................................................................................... 363
Clinical Data: .................................................................................................................................... 363
108) BUDESONIDE ........................................................................................................................... 365
Summary ......................................................................................................................................... 366

Originators ....................................................................................................................................... 366
Clinical Data: .................................................................................................................................... 366
109) BUDESONIDE (INHALED NEBULIZED, ASTHMA) ...................................................................... 368
Summary ......................................................................................................................................... 368

Originators ....................................................................................................................................... 368
Clinical Data: .................................................................................................................................... 368
110) BUPIVACAINE........................................................................................................................... 370
Summary ......................................................................................................................................... 371

Originators ....................................................................................................................................... 371

Clinical Data: .................................................................................................................................... 371
111) BUPRENORPHINE..................................................................................................................... 373
Summary ......................................................................................................................................... 373

Originators ....................................................................................................................................... 373
Clinical Data: .................................................................................................................................... 374
112) C-9280 ..................................................................................................................................... 376
Summary ......................................................................................................................................... 376

Originators ....................................................................................................................................... 376
Clinical Data: .................................................................................................................................... 376
113) C1-INH ..................................................................................................................................... 378
Summary ......................................................................................................................................... 378

Originators ....................................................................................................................................... 378
Clinical Data: .................................................................................................................................... 379
114) CA9-SCAN ................................................................................................................................ 381
Summary ......................................................................................................................................... 381

Originators ....................................................................................................................................... 381
Clinical Data: .................................................................................................................................... 381
115) CAIV-T ...................................................................................................................................... 383
Summary ......................................................................................................................................... 383

Originators ....................................................................................................................................... 384
Clinical Data: .................................................................................................................................... 384
116) CANFOSFAMIDE HCL ............................................................................................................... 386
Summary ......................................................................................................................................... 386

Originators ....................................................................................................................................... 386
Clinical Data: .................................................................................................................................... 386
117) CANGRELOR ............................................................................................................................. 388

Summary ......................................................................................................................................... 388
Originators ....................................................................................................................................... 389
Clinical Data: .................................................................................................................................... 389
118) CARBAMAZEPINE ..................................................................................................................... 391
Summary ......................................................................................................................................... 391

Originators ....................................................................................................................................... 391
Clinical Data: .................................................................................................................................... 391
119) CARBIDOPA + LEVODOPA CR ................................................................................................... 393
Summary ......................................................................................................................................... 394

Originators ....................................................................................................................................... 394
Clinical Data: .................................................................................................................................... 394
120) CARFILZOMIB ........................................................................................................................... 396
Summary ......................................................................................................................................... 396

Originators ....................................................................................................................................... 396
Clinical Data: .................................................................................................................................... 396
121) CARUMONAM ......................................................................................................................... 398
Summary ......................................................................................................................................... 399

Originators ....................................................................................................................................... 399
Clinical Data: .................................................................................................................................... 399
122) CBP-1011 ................................................................................................................................. 401
Summary ......................................................................................................................................... 401

Originators ....................................................................................................................................... 401
Clinical Data: .................................................................................................................................... 402
123) CCR9 ANTAGONIST .................................................................................................................. 404
Summary ......................................................................................................................................... 404

Originators ....................................................................................................................................... 404

Clinical Data: .................................................................................................................................... 404
124) CEE-04-410 .............................................................................................................................. 406
Summary ......................................................................................................................................... 406

Originators ....................................................................................................................................... 406
Clinical Data: .................................................................................................................................... 407
125) CEFTAROLINE ACETATE ........................................................................................................... 409
Summary ......................................................................................................................................... 409

Originators ....................................................................................................................................... 409
Clinical Data: .................................................................................................................................... 409
126) CEFTIZOXIME ALAPIVOXIL ....................................................................................................... 411
Summary ......................................................................................................................................... 411

Originators ....................................................................................................................................... 412
Clinical Data: .................................................................................................................................... 412
127) CELACADE TECHNOLOGY......................................................................................................... 414
Summary ......................................................................................................................................... 414

Originators ....................................................................................................................................... 414
Clinical Data: .................................................................................................................................... 414
128) CEM-102 .................................................................................................................................. 416
Summary ......................................................................................................................................... 416

Originators ....................................................................................................................................... 417
Clinical Data: .................................................................................................................................... 417
129) CETHROMYCIN......................................................................................................................... 419
Summary ......................................................................................................................................... 419

Originators ....................................................................................................................................... 419
Clinical Data: .................................................................................................................................... 419

130) CETILISTAT ............................................................................................................................... 421
Summary ......................................................................................................................................... 422

Originators ....................................................................................................................................... 422
Clinical Data: .................................................................................................................................... 422
131) CETRORELIX ............................................................................................................................. 424
Summary ......................................................................................................................................... 424

Originators ....................................................................................................................................... 424
Clinical Data: .................................................................................................................................... 424
132) CF-101 ...................................................................................................................................... 426
Summary ......................................................................................................................................... 427

Originators ....................................................................................................................................... 427
Clinical Data: .................................................................................................................................... 427
133) CHIMERIVAX-JE ........................................................................................................................ 429
Summary ......................................................................................................................................... 429

Originators ....................................................................................................................................... 429
Clinical Data: .................................................................................................................................... 430
134) CHLORPROGUANIL + DAPSONE + ARTESUNATE ..................................................................... 432
Summary ......................................................................................................................................... 432

Originators ....................................................................................................................................... 432
Clinical Data: .................................................................................................................................... 432
135) CICLOPIROX ............................................................................................................................. 434
Summary ......................................................................................................................................... 434

Originators ....................................................................................................................................... 434
Clinical Data: .................................................................................................................................... 435
136) CINTREDEKIN BESUDOTOX ...................................................................................................... 437
Summary ......................................................................................................................................... 437

Originators ....................................................................................................................................... 437
Clinical Data: .................................................................................................................................... 437
137) CISPLATIN ................................................................................................................................ 439
Summary ......................................................................................................................................... 439

Originators ....................................................................................................................................... 440
Clinical Data: .................................................................................................................................... 440
138) CITICOLINE ............................................................................................................................... 442
Summary ......................................................................................................................................... 442

Originators ....................................................................................................................................... 442
Clinical Data: .................................................................................................................................... 442
139) CLADRIBINE ............................................................................................................................. 444
Summary ......................................................................................................................................... 445

Originators ....................................................................................................................................... 445
Clinical Data: .................................................................................................................................... 445
140) CLAZOSENTAN ......................................................................................................................... 447
Summary ......................................................................................................................................... 447

Originators ....................................................................................................................................... 447
Clinical Data: .................................................................................................................................... 448
141) CLEVUDINE .............................................................................................................................. 450
Summary ......................................................................................................................................... 450

Originators ....................................................................................................................................... 450
Clinical Data: .................................................................................................................................... 450
142) CLINDAMYCIN .......................................................................................................................... 452
Summary ......................................................................................................................................... 452

Originators ....................................................................................................................................... 452

Clinical Data: .................................................................................................................................... 453
143) CLINDAMYCIN PHOSPHATE/TRETINOIN GEL ........................................................................... 455
Summary ......................................................................................................................................... 455

Originators ....................................................................................................................................... 455
Clinical Data: .................................................................................................................................... 455
144) CLOBAZAM .............................................................................................................................. 457
Summary ......................................................................................................................................... 457

Originators ....................................................................................................................................... 458
Clinical Data: .................................................................................................................................... 458
145) CLONIDINE HYDROCHLORIDE ER ............................................................................................. 460
Summary ......................................................................................................................................... 460

Originators ....................................................................................................................................... 460
Clinical Data: .................................................................................................................................... 460
146) CLOPIDOGREL .......................................................................................................................... 462
Summary ......................................................................................................................................... 462

Originators ....................................................................................................................................... 463
Clinical Data: .................................................................................................................................... 463
147) CM-AT ...................................................................................................................................... 465
Summary ......................................................................................................................................... 465

Originators ....................................................................................................................................... 465
Clinical Data: .................................................................................................................................... 465
148) CODEINE PHOSPHATE.............................................................................................................. 467
Summary ......................................................................................................................................... 468

Originators ....................................................................................................................................... 468
Clinical Data: .................................................................................................................................... 468
149) COLLARX GENTAMICIN SURGICAL IMPLANT ........................................................................... 470

Summary ......................................................................................................................................... 470
Originators ....................................................................................................................................... 470
Clinical Data: .................................................................................................................................... 470
150) COMBRETASTATIN-A4 PHOSPHATE ........................................................................................ 472
Summary ......................................................................................................................................... 473

Originators ....................................................................................................................................... 473
Clinical Data: .................................................................................................................................... 473
151) CP-690550 ............................................................................................................................... 475
Summary ......................................................................................................................................... 475

Originators ....................................................................................................................................... 475
Clinical Data: .................................................................................................................................... 476
152) CPC-211 ................................................................................................................................... 478
Summary ......................................................................................................................................... 478

Originators ....................................................................................................................................... 478
Clinical Data: .................................................................................................................................... 478
153) CROFELEMER ........................................................................................................................... 480
Summary ......................................................................................................................................... 480

Originators ....................................................................................................................................... 480
Clinical Data: .................................................................................................................................... 481
154) CTP-37...................................................................................................................................... 483
Summary ......................................................................................................................................... 483

Originators ....................................................................................................................................... 483
Clinical Data: .................................................................................................................................... 483
155) CV-247 ..................................................................................................................................... 485
Summary ......................................................................................................................................... 485

Originators ....................................................................................................................................... 486

Clinical Data: .................................................................................................................................... 486
156) CX-401 ..................................................................................................................................... 488
Summary ......................................................................................................................................... 488

Originators ....................................................................................................................................... 488
Clinical Data: .................................................................................................................................... 488
157) CYANOCOBALAMIN (ALLERGIC RHINITIS)................................................................................ 490
Summary ......................................................................................................................................... 490

Originators ....................................................................................................................................... 491
Clinical Data: .................................................................................................................................... 491
158) CYCLOSPORINE ........................................................................................................................ 493
Summary ......................................................................................................................................... 493

Originators ....................................................................................................................................... 493
Clinical Data: .................................................................................................................................... 493
159) CYCLOSPORINE A (DRY EYE) .................................................................................................... 495
Summary ......................................................................................................................................... 496

Originators ....................................................................................................................................... 496
Clinical Data: .................................................................................................................................... 496
160) CYCLOSPORINE A (VERNAL KERATOCONJUNCTIVITIS) ............................................................ 498
Summary ......................................................................................................................................... 498

Originators ....................................................................................................................................... 498
Clinical Data: .................................................................................................................................... 498
161) CYPROTERONE ......................................................................................................................... 500
Summary ......................................................................................................................................... 501

Originators ....................................................................................................................................... 501
Clinical Data: .................................................................................................................................... 501

162) CYTOMEGALOVIRUS CELL THERAPY ........................................................................................ 503
Summary ......................................................................................................................................... 503

Originators ....................................................................................................................................... 503
Clinical Data: .................................................................................................................................... 504
163) DACLIZUMAB ........................................................................................................................... 506
Summary ......................................................................................................................................... 506

Originators ....................................................................................................................................... 506
Clinical Data: .................................................................................................................................... 506
164) DAPAGLIFLOZIN ....................................................................................................................... 508
Summary ......................................................................................................................................... 508

Originators ....................................................................................................................................... 508
Clinical Data: .................................................................................................................................... 509
165) DAPOXETINE ............................................................................................................................ 511
Summary ......................................................................................................................................... 511

Originators ....................................................................................................................................... 511
Clinical Data: .................................................................................................................................... 511
166) DARAPLADIB ............................................................................................................................ 513
Summary ......................................................................................................................................... 513

Originators ....................................................................................................................................... 514
Clinical Data: .................................................................................................................................... 514
167) DARUSENTAN .......................................................................................................................... 516
Summary ......................................................................................................................................... 516

Originators ....................................................................................................................................... 516
Clinical Data: .................................................................................................................................... 516
168) DCVAX-PROSTATE.................................................................................................................... 518
Summary ......................................................................................................................................... 518

Originators ....................................................................................................................................... 519
Clinical Data: .................................................................................................................................... 519
169) DEFIBROTIDE ........................................................................................................................... 521
Summary ......................................................................................................................................... 521

Originators ....................................................................................................................................... 521
Clinical Data: .................................................................................................................................... 521
170) DEGLUDEC ............................................................................................................................... 523
Summary ......................................................................................................................................... 524

Originators ....................................................................................................................................... 524
Clinical Data: .................................................................................................................................... 524
171) DEHYDRODIDEMNIN B ............................................................................................................ 526
Summary ......................................................................................................................................... 527

Originators ....................................................................................................................................... 527
Clinical Data: .................................................................................................................................... 527
172) DENOSUMAB ........................................................................................................................... 529
Summary ......................................................................................................................................... 529

Originators ....................................................................................................................................... 529
Clinical Data: .................................................................................................................................... 530
173) DEPOBUPIVACAINE.................................................................................................................. 532
Summary ......................................................................................................................................... 532

Originators ....................................................................................................................................... 532
Clinical Data: .................................................................................................................................... 532
174) DESLORATADINE ...................................................................................................................... 534
Summary ......................................................................................................................................... 534

Originators ....................................................................................................................................... 534

Clinical Data: .................................................................................................................................... 535
175) DESLORELIN + ESTRADIOL + TESTOSTERONE .......................................................................... 537
Summary ......................................................................................................................................... 537

Originators ....................................................................................................................................... 537
Clinical Data: .................................................................................................................................... 537
176) DESMOTEPLASE ....................................................................................................................... 539
Summary ......................................................................................................................................... 539

Originators ....................................................................................................................................... 540
Clinical Data: .................................................................................................................................... 540
177) DESONIDE ................................................................................................................................ 542
Summary ......................................................................................................................................... 542

Originators ....................................................................................................................................... 542
Clinical Data: .................................................................................................................................... 542
178) DEXAMETHASONE ................................................................................................................... 544
Summary ......................................................................................................................................... 544

Originators ....................................................................................................................................... 545
Clinical Data: .................................................................................................................................... 545
179) DEXLOXIGLUMIDE.................................................................................................................... 547
Summary ......................................................................................................................................... 547

Originators ....................................................................................................................................... 547
Clinical Data: .................................................................................................................................... 547
180) DEXTROMETHORPHAN + QUINIDINE ...................................................................................... 549
Summary ......................................................................................................................................... 550

Originators ....................................................................................................................................... 550
Clinical Data: .................................................................................................................................... 550
181) DG-031..................................................................................................................................... 552

Summary ......................................................................................................................................... 552
Originators ....................................................................................................................................... 552
Clinical Data: .................................................................................................................................... 552
182) DIAMYD DIABETES VACCINE.................................................................................................... 554
Summary ......................................................................................................................................... 555

Originators ....................................................................................................................................... 555
Clinical Data: .................................................................................................................................... 555
183) DIAPEP-277 .............................................................................................................................. 557
Summary ......................................................................................................................................... 557

Originators ....................................................................................................................................... 557
Clinical Data: .................................................................................................................................... 558
184) DICLOFENAC SODIUM ............................................................................................................. 560
Summary ......................................................................................................................................... 560

Originators ....................................................................................................................................... 560
Clinical Data: .................................................................................................................................... 560
185) DIFLUPREDNATE ...................................................................................................................... 562
Summary ......................................................................................................................................... 562

Originators ....................................................................................................................................... 562
Clinical Data: .................................................................................................................................... 563
186) DIHYDROARTEMISININ + PIPERAQUINE .................................................................................. 565
Summary ......................................................................................................................................... 565

Originators ....................................................................................................................................... 565
Clinical Data: .................................................................................................................................... 565
187) DILTIAZEM HYDROCHLORIDE .................................................................................................. 567
Summary ......................................................................................................................................... 567

Originators ....................................................................................................................................... 568

Clinical Data: .................................................................................................................................... 568
188) DIMEBON ................................................................................................................................. 570
Summary ......................................................................................................................................... 570

Originators ....................................................................................................................................... 570
Clinical Data: .................................................................................................................................... 570
189) DIMETHYL FUMARATE ............................................................................................................. 572
Summary ......................................................................................................................................... 572

Originators ....................................................................................................................................... 573
Clinical Data: .................................................................................................................................... 573
190) DIQUAFOSOL TETRASODIUM .................................................................................................. 575
Summary ......................................................................................................................................... 575

Originators ....................................................................................................................................... 575
Clinical Data: .................................................................................................................................... 575
191) DIRUCOTIDE............................................................................................................................. 577
Summary ......................................................................................................................................... 578

Originators ....................................................................................................................................... 578
Clinical Data: .................................................................................................................................... 578
192) DN-101..................................................................................................................................... 580
Summary ......................................................................................................................................... 580

Originators ....................................................................................................................................... 580
Clinical Data: .................................................................................................................................... 580
193) DOXORUBICIN (HEAT-SENSITIVE LIPOSOMAL ......................................................................... 582
Summary ......................................................................................................................................... 583

Originators ....................................................................................................................................... 583
Clinical Data: .................................................................................................................................... 583

194) DP-B99 ..................................................................................................................................... 585
Summary ......................................................................................................................................... 585

Originators ....................................................................................................................................... 585
Clinical Data: .................................................................................................................................... 586
195) DROXIDOPA ............................................................................................................................. 588
Summary ......................................................................................................................................... 588

Originators ....................................................................................................................................... 588
Clinical Data: .................................................................................................................................... 588
196) DTP-HBV-POLIO-HIB VACCINE ................................................................................................. 590
Summary ......................................................................................................................................... 590

Originators ....................................................................................................................................... 590
Clinical Data: .................................................................................................................................... 591
197) DTPW-HBV VACCINE................................................................................................................ 593
Summary ......................................................................................................................................... 593

Originators ....................................................................................................................................... 593
Clinical Data: .................................................................................................................................... 593
198) DUTOGLIPTIN........................................................................................................................... 595
Summary ......................................................................................................................................... 595

Originators ....................................................................................................................................... 596
Clinical Data: .................................................................................................................................... 596
199) DWP-412.................................................................................................................................. 598
Summary ......................................................................................................................................... 598

Originators ....................................................................................................................................... 598
Clinical Data: .................................................................................................................................... 598
200) DWP-413.................................................................................................................................. 600
Summary ......................................................................................................................................... 600

Originators ....................................................................................................................................... 601
Clinical Data: .................................................................................................................................... 601
201) ECADOTRIL............................................................................................................................... 603
Summary ......................................................................................................................................... 603

Originators ....................................................................................................................................... 603
Clinical Data: .................................................................................................................................... 603
202) ECALLANTIDE ........................................................................................................................... 605
Summary ......................................................................................................................................... 606

Originators ....................................................................................................................................... 606
Clinical Data: .................................................................................................................................... 606
203) EDOXABAN TOSYLATE ............................................................................................................. 608
Summary ......................................................................................................................................... 608

Originators ....................................................................................................................................... 608
Clinical Data: .................................................................................................................................... 608
204) EFLETIRIZINE ............................................................................................................................ 610
Summary ......................................................................................................................................... 611

Originators ....................................................................................................................................... 611
Clinical Data: .................................................................................................................................... 611
205) EG-006 ..................................................................................................................................... 613
Summary ......................................................................................................................................... 613

Originators ....................................................................................................................................... 613
Clinical Data: .................................................................................................................................... 614
206) EGB-761 ................................................................................................................................... 616
Summary ......................................................................................................................................... 616

Originators ....................................................................................................................................... 616

Clinical Data: .................................................................................................................................... 616
207) EGP-437 ................................................................................................................................... 618
Summary ......................................................................................................................................... 618

Originators ....................................................................................................................................... 618
Clinical Data: .................................................................................................................................... 619
208) EHT-201 ................................................................................................................................... 621
Summary ......................................................................................................................................... 621

Originators ....................................................................................................................................... 621
Clinical Data: .................................................................................................................................... 621
209) ELDECALCITOL ......................................................................................................................... 623
Summary ......................................................................................................................................... 623

Originators ....................................................................................................................................... 624
Clinical Data: .................................................................................................................................... 624
210) ELESCLOMOL ........................................................................................................................... 626
Summary ......................................................................................................................................... 626

Originators ....................................................................................................................................... 626
Clinical Data: .................................................................................................................................... 626
211) ELIGLUSTAT TARTRATE ............................................................................................................ 628
Summary ......................................................................................................................................... 628

Originators ....................................................................................................................................... 629
Clinical Data: .................................................................................................................................... 629
212) ELVITEGRAVIR .......................................................................................................................... 631
Summary ......................................................................................................................................... 631

Originators ....................................................................................................................................... 631
Clinical Data: .................................................................................................................................... 631
213) ELVITEGRAVIR + COBICISTAT + TRUVADA ............................................................................... 633

Summary ......................................................................................................................................... 634
Originators ....................................................................................................................................... 634
Clinical Data: .................................................................................................................................... 634
214) EN-3231 ................................................................................................................................... 636
Summary ......................................................................................................................................... 636

Originators ....................................................................................................................................... 636
Clinical Data: .................................................................................................................................... 636
215) ENCLOMIPHENE....................................................................................................................... 638
Summary ......................................................................................................................................... 639

Originators ....................................................................................................................................... 639
Clinical Data: .................................................................................................................................... 639
216) ENDOMETRION........................................................................................................................ 641
Summary ......................................................................................................................................... 641

Originators ....................................................................................................................................... 641
Clinical Data: .................................................................................................................................... 642
217) EPIRETINAL BRACHYTHERAPY ................................................................................................. 644
Summary ......................................................................................................................................... 644

Originators ....................................................................................................................................... 644
Clinical Data: .................................................................................................................................... 644
218) EPLERENONE ........................................................................................................................... 646
Summary ......................................................................................................................................... 646

Originators ....................................................................................................................................... 646
Clinical Data: .................................................................................................................................... 647
219) EPOETIN OMEGA ..................................................................................................................... 649
Summary ......................................................................................................................................... 649

Originators ....................................................................................................................................... 649

Clinical Data: .................................................................................................................................... 649
220) EPRATUZUMAB........................................................................................................................ 651
Summary ......................................................................................................................................... 651

Originators ....................................................................................................................................... 652
Clinical Data: .................................................................................................................................... 652
221) EPRODISATE............................................................................................................................. 654
Summary ......................................................................................................................................... 654

Originators ....................................................................................................................................... 654
Clinical Data: .................................................................................................................................... 654
222) EPTOTERMIN ALFA .................................................................................................................. 656
Summary ......................................................................................................................................... 656

Originators ....................................................................................................................................... 657
Clinical Data: .................................................................................................................................... 657
223) ERITORAN TETRASODIUM ....................................................................................................... 659
Summary ......................................................................................................................................... 659

Originators ....................................................................................................................................... 659
Clinical Data: .................................................................................................................................... 659
224) ESLICARBAZEPINE ACETATE..................................................................................................... 661
Summary ......................................................................................................................................... 662

Originators ....................................................................................................................................... 662
Clinical Data: .................................................................................................................................... 662
225) ESOXYBUTYNIN ........................................................................................................................ 664
Summary ......................................................................................................................................... 664

Originators ....................................................................................................................................... 664
Clinical Data: .................................................................................................................................... 664

226) ESREBOXETINE ......................................................................................................................... 666
Summary ......................................................................................................................................... 667

Originators ....................................................................................................................................... 667
Clinical Data: .................................................................................................................................... 667
227) ESTRADIOL + LEVONORGESTREL TRANSDERMAL.................................................................... 669
Summary ......................................................................................................................................... 669

Originators ....................................................................................................................................... 669
Clinical Data: .................................................................................................................................... 670
228) ESTROGEN/PROGESTOGEN COMBINATION GEL ..................................................................... 672
Summary ......................................................................................................................................... 672

Originators ....................................................................................................................................... 672
Clinical Data: .................................................................................................................................... 672
229) ETHEOPHAZINE ........................................................................................................................ 674
Summary ......................................................................................................................................... 674

Originators ....................................................................................................................................... 674
Clinical Data: .................................................................................................................................... 675
230) EXTENDED RELEASE NIACIN + LAROPIPRANT + ....................................................................... 677
Summary ......................................................................................................................................... 677

Originators ....................................................................................................................................... 677
Clinical Data: .................................................................................................................................... 677
231) FASORACETAM ........................................................................................................................ 679
Summary ......................................................................................................................................... 679

Originators ....................................................................................................................................... 680
Clinical Data: .................................................................................................................................... 680
232) FENANTYL ................................................................................................................................ 682
Summary ......................................................................................................................................... 682

Originators ....................................................................................................................................... 682
Clinical Data: .................................................................................................................................... 682
233) FENTANYL SUBLINGUAL SPRAY ............................................................................................... 684
Summary ......................................................................................................................................... 684

Originators ....................................................................................................................................... 685
Clinical Data: .................................................................................................................................... 685
234) FIGITUMUMAB ........................................................................................................................ 687
Summary ......................................................................................................................................... 687

Originators ....................................................................................................................................... 687
Clinical Data: .................................................................................................................................... 687
235) FLIBANSERIN ............................................................................................................................ 689
Summary ......................................................................................................................................... 690

Originators ....................................................................................................................................... 690
Clinical Data: .................................................................................................................................... 690
236) FLUOXETINE (AUTISM) ............................................................................................................ 692
Summary ......................................................................................................................................... 692

Originators ....................................................................................................................................... 692
Clinical Data: .................................................................................................................................... 692
237) FLUTICASONE + AZELASTINE ................................................................................................... 694
Summary ......................................................................................................................................... 695

Originators ....................................................................................................................................... 695
Clinical Data: .................................................................................................................................... 695
238) FLUTICASONE + FORMOTEROL ................................................................................................ 697
Summary ......................................................................................................................................... 697

Originators ....................................................................................................................................... 697

Clinical Data: .................................................................................................................................... 698
239) FOSPHENYTOIN SODIUM ......................................................................................................... 700
Summary ......................................................................................................................................... 700

Originators ....................................................................................................................................... 700
Clinical Data: .................................................................................................................................... 700
240) GABAPENTIN............................................................................................................................ 702
Summary ......................................................................................................................................... 702

Originators ....................................................................................................................................... 702
Clinical Data: .................................................................................................................................... 703
241) GABEXATE MESILATE ............................................................................................................... 705
Summary ......................................................................................................................................... 705

Originators ....................................................................................................................................... 705
Clinical Data: .................................................................................................................................... 705
242) GADOMELITOL ......................................................................................................................... 707
Summary ......................................................................................................................................... 707

Originators ....................................................................................................................................... 708
Clinical Data: .................................................................................................................................... 708
243) GALACTOMANNAN-C .............................................................................................................. 710
Summary ......................................................................................................................................... 710

Originators ....................................................................................................................................... 710
Clinical Data: .................................................................................................................................... 710
244) GALIXIMAB .............................................................................................................................. 712
Summary ......................................................................................................................................... 712

Originators ....................................................................................................................................... 713
Clinical Data: .................................................................................................................................... 713
245) GARENOXACIN......................................................................................................................... 715

Summary ......................................................................................................................................... 715
Originators ....................................................................................................................................... 715
Clinical Data: .................................................................................................................................... 715
246) GASTRIMMUNE ....................................................................................................................... 717
Summary ......................................................................................................................................... 718

Originators ....................................................................................................................................... 718
Clinical Data: .................................................................................................................................... 718
247) GENE THERAPY (LYMPHOMA) ................................................................................................. 720
Summary ......................................................................................................................................... 720

Originators ....................................................................................................................................... 720
Clinical Data: .................................................................................................................................... 720
248) GEPIRONE ................................................................................................................................ 722
Summary ......................................................................................................................................... 723

Originators ....................................................................................................................................... 723
Clinical Data: .................................................................................................................................... 723
249) GINGER EXTRACT ..................................................................................................................... 725
Summary ......................................................................................................................................... 725

Originators ....................................................................................................................................... 725
Clinical Data: .................................................................................................................................... 726
250) GLUFOSFAMIDE ....................................................................................................................... 728
Summary ......................................................................................................................................... 728

Originators ....................................................................................................................................... 728
Clinical Data: .................................................................................................................................... 728
251) GLYCOPYRROLATE ................................................................................................................... 730
Summary ......................................................................................................................................... 730

Originators ....................................................................................................................................... 730

Clinical Data: .................................................................................................................................... 731
252) GLYMINOX ............................................................................................................................... 733
Summary ......................................................................................................................................... 733

Originators ....................................................................................................................................... 733
Clinical Data: .................................................................................................................................... 733
253) GLYPROMATE .......................................................................................................................... 735
Summary ......................................................................................................................................... 735

Originators ....................................................................................................................................... 736
Clinical Data: .................................................................................................................................... 736
254) GMK ......................................................................................................................................... 738
Summary ......................................................................................................................................... 738

Originators ....................................................................................................................................... 738
Clinical Data: .................................................................................................................................... 738
255) GRANISETRON HYDROCHLORIDE ............................................................................................ 740
Summary ......................................................................................................................................... 740

Originators ....................................................................................................................................... 741
Clinical Data: .................................................................................................................................... 741
256) GRANISETRON TRANSDERMAL DELIVERY SYSTEM ................................................................. 743
Summary ......................................................................................................................................... 743

Originators ....................................................................................................................................... 743
Clinical Data: .................................................................................................................................... 743
257) GRASPA .................................................................................................................................... 745
Summary ......................................................................................................................................... 746

Originators ....................................................................................................................................... 746
Clinical Data: .................................................................................................................................... 746

258) GRASS POLLEN ALLERGY DESENSITIZATION TABLET ............................................................... 748
Summary ......................................................................................................................................... 748

Originators ....................................................................................................................................... 748
Clinical Data: .................................................................................................................................... 748
259) GRASS POLLEN IMMUNOTHERAPY ......................................................................................... 750
Summary ......................................................................................................................................... 751

Originators ....................................................................................................................................... 751
Clinical Data: .................................................................................................................................... 751
260) GROWTH HORMONE ............................................................................................................... 753
Summary ......................................................................................................................................... 753

Originators ....................................................................................................................................... 753
Clinical Data: .................................................................................................................................... 754
261) GS-101 ..................................................................................................................................... 756
Summary ......................................................................................................................................... 756

Originators ....................................................................................................................................... 756
Clinical Data: .................................................................................................................................... 756
262) GV-1001 ................................................................................................................................... 758
Summary ......................................................................................................................................... 758

Originators ....................................................................................................................................... 758
Clinical Data: .................................................................................................................................... 759
263) GW-1000.................................................................................................................................. 761
Summary ......................................................................................................................................... 761

Originators ....................................................................................................................................... 761
Clinical Data: .................................................................................................................................... 761
264) GW-406381.............................................................................................................................. 763
Summary ......................................................................................................................................... 763

Originators ....................................................................................................................................... 764
Clinical Data: .................................................................................................................................... 764
265) HAEMOPHILUS INFLUENZAE B VACCINE ................................................................................. 766
Summary ......................................................................................................................................... 766

Originators ....................................................................................................................................... 766
Clinical Data: .................................................................................................................................... 766
266) HBV-ISS .................................................................................................................................... 768
Summary ......................................................................................................................................... 768

Originators ....................................................................................................................................... 769
Clinical Data: .................................................................................................................................... 769
267) HEMATIDE ............................................................................................................................... 771
Summary ......................................................................................................................................... 771

Originators ....................................................................................................................................... 771
Clinical Data: .................................................................................................................................... 771
268) HEMOSPAN.............................................................................................................................. 773
Summary ......................................................................................................................................... 774

Originators ....................................................................................................................................... 774
Clinical Data: .................................................................................................................................... 774
269) HEPATITIS B VACCINE .............................................................................................................. 776
Summary ......................................................................................................................................... 776

Originators ....................................................................................................................................... 776
Clinical Data: .................................................................................................................................... 776
270) HFA NITROGLYCERIN SPRAY .................................................................................................... 778
Summary ......................................................................................................................................... 779

Originators ....................................................................................................................................... 779

Clinical Data: .................................................................................................................................... 779
271) HIB-MENCY-TT ......................................................................................................................... 781
Summary ......................................................................................................................................... 781

Originators ....................................................................................................................................... 781
Clinical Data: .................................................................................................................................... 782
272) HIGH RATIO THC ...................................................................................................................... 784
Summary ......................................................................................................................................... 784

Originators ....................................................................................................................................... 784
Clinical Data: .................................................................................................................................... 784
273) HR5I ......................................................................................................................................... 786
Summary ......................................................................................................................................... 786

Originators ....................................................................................................................................... 786
Clinical Data: .................................................................................................................................... 787
274) HRA-052015............................................................................................................................. 789
Summary ......................................................................................................................................... 789

Originators ....................................................................................................................................... 789
Clinical Data: .................................................................................................................................... 789
275) HUMAN FGF1 GENE THERAPY ................................................................................................. 791
Summary ......................................................................................................................................... 791

Originators ....................................................................................................................................... 792
Clinical Data: .................................................................................................................................... 792
276) HUMAX-EGFR .......................................................................................................................... 794
Summary ......................................................................................................................................... 794

Originators ....................................................................................................................................... 794
Clinical Data: .................................................................................................................................... 794
277) HYDROCODONE BITARTRATE (CONTROLLED RELEASE) .......................................................... 796

Summary ......................................................................................................................................... 796
Originators ....................................................................................................................................... 797
Clinical Data: .................................................................................................................................... 797
278) HYDROMORPHONE HYDROCHLORIDE .................................................................................... 799
Summary ......................................................................................................................................... 799

Originators ....................................................................................................................................... 799
Clinical Data: .................................................................................................................................... 799
279) HYLASTAN ................................................................................................................................ 801
Summary ......................................................................................................................................... 802

Originators ....................................................................................................................................... 802
Clinical Data: .................................................................................................................................... 802
280) HYPERACUTE PANCREAS ......................................................................................................... 804
Summary ......................................................................................................................................... 804

Originators ....................................................................................................................................... 804
Clinical Data: .................................................................................................................................... 804
281) IBUPROFEN .............................................................................................................................. 806
Summary ......................................................................................................................................... 807

Originators ....................................................................................................................................... 807
Clinical Data: .................................................................................................................................... 807
282) IBUPROFEN + FAMOTIDINE ..................................................................................................... 809
Summary ......................................................................................................................................... 809

Originators ....................................................................................................................................... 809
Clinical Data: .................................................................................................................................... 810
283) IBUPROFEN + PHOSPHATIDYLCHOLINE ................................................................................... 812
Summary ......................................................................................................................................... 812

Originators ....................................................................................................................................... 812

Clinical Data: .................................................................................................................................... 812
284) ICX-PRO.................................................................................................................................... 814
Summary ......................................................................................................................................... 814

Originators ....................................................................................................................................... 814
Clinical Data: .................................................................................................................................... 815
285) IDM-2 ....................................................................................................................................... 817
Summary ......................................................................................................................................... 817

Originators ....................................................................................................................................... 817
Clinical Data: .................................................................................................................................... 817
286) IDP-108 .................................................................................................................................... 819
Summary ......................................................................................................................................... 819

Originators ....................................................................................................................................... 820
Clinical Data: .................................................................................................................................... 820
287) IDP-115 .................................................................................................................................... 822
Summary ......................................................................................................................................... 822

Originators ....................................................................................................................................... 822
Clinical Data: .................................................................................................................................... 822
288) IDRAPARINUX SODIUM ........................................................................................................... 824
Summary ......................................................................................................................................... 824

Originators ....................................................................................................................................... 825
Clinical Data: .................................................................................................................................... 825
289) IGN-101.................................................................................................................................... 827
Summary ......................................................................................................................................... 827

Originators ....................................................................................................................................... 827
Clinical Data: .................................................................................................................................... 827

290) IGURATIMOD (SIMCERE) ......................................................................................................... 829
Summary ......................................................................................................................................... 830

Originators ....................................................................................................................................... 830
Clinical Data: .................................................................................................................................... 830
291) IMC-1121B ............................................................................................................................... 832
Summary ......................................................................................................................................... 832

Originators ....................................................................................................................................... 832
Clinical Data: .................................................................................................................................... 832
292) IMMUNE GLOBULIN INTRAVENOUS (HUMAN) ....................................................................... 834
Summary ......................................................................................................................................... 835

Originators ....................................................................................................................................... 835
Clinical Data: .................................................................................................................................... 835
293) INFLUENZA VACCINE ............................................................................................................... 837
Summary ......................................................................................................................................... 837

Originators ....................................................................................................................................... 837
Clinical Data: .................................................................................................................................... 838
294) INFLUENZA VACCINE (CELL CULTURE) ..................................................................................... 840
Summary ......................................................................................................................................... 840

Originators ....................................................................................................................................... 840
Clinical Data: .................................................................................................................................... 840
295) INGENOL MEBUTATE ............................................................................................................... 842
Summary ......................................................................................................................................... 842

Originators ....................................................................................................................................... 842
Clinical Data: .................................................................................................................................... 843
296) INGN-241 ................................................................................................................................. 845
Summary ......................................................................................................................................... 845

Originators ....................................................................................................................................... 845
Clinical Data: .................................................................................................................................... 845
297) INHALED DIHYDROERGOTAMINE ............................................................................................ 847
Summary ......................................................................................................................................... 847

Originators ....................................................................................................................................... 848
Clinical Data: .................................................................................................................................... 848
298) INHALED FENTANYL ................................................................................................................. 850
Summary ......................................................................................................................................... 850

Originators ....................................................................................................................................... 850
Clinical Data: .................................................................................................................................... 850
299) INHALED TREPROSTINIL........................................................................................................... 852
Summary ......................................................................................................................................... 852

Originators ....................................................................................................................................... 853
Clinical Data: .................................................................................................................................... 853
300) INSULIN INHALED (RECOMBINANT HUMAN INSULIN) ............................................................ 855
Summary ......................................................................................................................................... 855

Originators ....................................................................................................................................... 855
Clinical Data: .................................................................................................................................... 855
301) INTERFERON ALFA-N1 ............................................................................................................. 857
Summary ......................................................................................................................................... 858

Originators ....................................................................................................................................... 858
Clinical Data: .................................................................................................................................... 858
302) INTERFERON ALFA-N3 (INJECTION) ......................................................................................... 860
Summary ......................................................................................................................................... 860

Originators ....................................................................................................................................... 860

Clinical Data: .................................................................................................................................... 860
303) INTERFERON ALFA-N3 (ORAL) ................................................................................................. 862
Summary ......................................................................................................................................... 863

Originators ....................................................................................................................................... 863
Clinical Data: .................................................................................................................................... 863
304) INTERFERON BETA-1A ............................................................................................................. 865
Summary ......................................................................................................................................... 865

Originators ....................................................................................................................................... 865
Clinical Data: .................................................................................................................................... 866
305) INTRANASAL KETAMINE .......................................................................................................... 868
Summary ......................................................................................................................................... 868

Originators ....................................................................................................................................... 868
Clinical Data: .................................................................................................................................... 868
306) IOGEN ...................................................................................................................................... 870
Summary ......................................................................................................................................... 870

Originators ....................................................................................................................................... 870
Clinical Data: .................................................................................................................................... 871
307) IOR T1 ANTIBODY .................................................................................................................... 873
Summary ......................................................................................................................................... 873

Originators ....................................................................................................................................... 873
Clinical Data: .................................................................................................................................... 873
308) IOSIMENOL .............................................................................................................................. 875
Summary ......................................................................................................................................... 875

Originators ....................................................................................................................................... 876
Clinical Data: .................................................................................................................................... 876
309) IPILIMUMAB ............................................................................................................................ 878

Summary ......................................................................................................................................... 878
Originators ....................................................................................................................................... 878
Clinical Data: .................................................................................................................................... 878
310) IRBESARTAN............................................................................................................................. 880
Summary ......................................................................................................................................... 880

Originators ....................................................................................................................................... 881
Clinical Data: .................................................................................................................................... 881
311) ISAVUCONAZOLE ..................................................................................................................... 883
Summary ......................................................................................................................................... 883

Originators ....................................................................................................................................... 883
Clinical Data: .................................................................................................................................... 883
312) ITRACONAZOLE ........................................................................................................................ 885
Summary ......................................................................................................................................... 886

Originators ....................................................................................................................................... 886
Clinical Data: .................................................................................................................................... 886
313) IXOC-2 ...................................................................................................................................... 888
Summary ......................................................................................................................................... 888

Originators ....................................................................................................................................... 888
Clinical Data: .................................................................................................................................... 888
314) JAK2 TYROSINE KINASE INHIBITORS ........................................................................................ 890
Summary ......................................................................................................................................... 891

Originators ....................................................................................................................................... 891
Clinical Data: .................................................................................................................................... 891
315) JR-013 ...................................................................................................................................... 893
Summary ......................................................................................................................................... 893

Originators ....................................................................................................................................... 893

Clinical Data: .................................................................................................................................... 894
316) JRF-8909 .................................................................................................................................. 896
Summary ......................................................................................................................................... 896

Originators ....................................................................................................................................... 896
Clinical Data: .................................................................................................................................... 896
317) KETOCONAZOLE + DESONIDE .................................................................................................. 898
Summary ......................................................................................................................................... 898

Originators ....................................................................................................................................... 898
Clinical Data: .................................................................................................................................... 899
318) KLH........................................................................................................................................... 901
Summary ......................................................................................................................................... 901

Originators ....................................................................................................................................... 901
Clinical Data: .................................................................................................................................... 901
319) KP-102 PROGRAM ................................................................................................................... 903
Summary ......................................................................................................................................... 903

Originators ....................................................................................................................................... 904
Clinical Data: .................................................................................................................................... 904
320) KREMEZIN ................................................................................................................................ 906
Summary ......................................................................................................................................... 906

Originators ....................................................................................................................................... 906
Clinical Data: .................................................................................................................................... 906
321) LACOSAMIDE ........................................................................................................................... 908
Summary ......................................................................................................................................... 908

Originators ....................................................................................................................................... 909
Clinical Data: .................................................................................................................................... 909

322) LANTHANUM CARBONATE ...................................................................................................... 911
Summary ......................................................................................................................................... 911

Originators ....................................................................................................................................... 911
Clinical Data: .................................................................................................................................... 911
323) LAQUINIMOD........................................................................................................................... 913
Summary ......................................................................................................................................... 914

Originators ....................................................................................................................................... 914
Clinical Data: .................................................................................................................................... 914
324) LAS-34475 ................................................................................................................................ 916
Summary ......................................................................................................................................... 916

Originators ....................................................................................................................................... 916
Clinical Data: .................................................................................................................................... 916
325) LATANOPROST + TIMOLOL ...................................................................................................... 918
Summary ......................................................................................................................................... 919

Originators ....................................................................................................................................... 919
Clinical Data: .................................................................................................................................... 919
326) LAX-101.................................................................................................................................... 921
Summary ......................................................................................................................................... 921

Originators ....................................................................................................................................... 921
Clinical Data: .................................................................................................................................... 922
327) LDI-200..................................................................................................................................... 924
Summary ......................................................................................................................................... 924

Originators ....................................................................................................................................... 924
Clinical Data: .................................................................................................................................... 924
328) LESTAURTINIB .......................................................................................................................... 926
Summary ......................................................................................................................................... 926

Originators ....................................................................................................................................... 926
Clinical Data: .................................................................................................................................... 927
329) LEUPROLIDE ACETATE IMPLANT (CNS).................................................................................... 929
Summary ......................................................................................................................................... 929

Originators ....................................................................................................................................... 929
Clinical Data: .................................................................................................................................... 929
330) LEVOFOLINIC ACID ................................................................................................................... 931
Summary ......................................................................................................................................... 931

Originators ....................................................................................................................................... 932
Clinical Data: .................................................................................................................................... 932
331) LEXIPAFANT (IV FORMULATION) ............................................................................................. 934
Summary ......................................................................................................................................... 934

Originators ....................................................................................................................................... 934
Clinical Data: .................................................................................................................................... 934
332) LIAROZOLE ............................................................................................................................... 936
Summary ......................................................................................................................................... 936

Originators ....................................................................................................................................... 937
Clinical Data: .................................................................................................................................... 937
333) LICARBAZEPINE ........................................................................................................................ 939
Summary ......................................................................................................................................... 939

Originators ....................................................................................................................................... 939
Clinical Data: .................................................................................................................................... 939
334) LIDOCAINE ............................................................................................................................... 941
Summary ......................................................................................................................................... 942

Originators ....................................................................................................................................... 942

Clinical Data: .................................................................................................................................... 942
335) LIDOCAINE PATCH ................................................................................................................... 944
Summary ......................................................................................................................................... 944

Originators ....................................................................................................................................... 944
Clinical Data: .................................................................................................................................... 944
336) LIDOCAINE TRANSDERMAL PATCH .......................................................................................... 946
Summary ......................................................................................................................................... 947

Originators ....................................................................................................................................... 947
Clinical Data: .................................................................................................................................... 947
337) LIDOCAINE; PRILOCAINE .......................................................................................................... 949
Summary ......................................................................................................................................... 949

Originators ....................................................................................................................................... 949
Clinical Data: .................................................................................................................................... 950
338) LINACLOTIDE............................................................................................................................ 952
Summary ......................................................................................................................................... 952

Originators ....................................................................................................................................... 952
Clinical Data: .................................................................................................................................... 952
339) LIPOSOMAL CISPLATIN ............................................................................................................ 954
Summary ......................................................................................................................................... 954

Originators ....................................................................................................................................... 954
Clinical Data: .................................................................................................................................... 955
340) LIPROTAMASE.......................................................................................................................... 957
Summary ......................................................................................................................................... 957

Originators ....................................................................................................................................... 957
Clinical Data: .................................................................................................................................... 957
341) LISURIDE .................................................................................................................................. 959

Summary ......................................................................................................................................... 959
Originators ....................................................................................................................................... 960
Clinical Data: .................................................................................................................................... 960
342) LITX .......................................................................................................................................... 962
Summary ......................................................................................................................................... 962

Originators ....................................................................................................................................... 962
Clinical Data: .................................................................................................................................... 962
343) LIXISENATIDE ........................................................................................................................... 964
Summary ......................................................................................................................................... 964

Originators ....................................................................................................................................... 965
Clinical Data: .................................................................................................................................... 965
344) LIXIVAPTAN .............................................................................................................................. 967
Summary ......................................................................................................................................... 967

Originators ....................................................................................................................................... 967
Clinical Data: .................................................................................................................................... 967
345) LOFEXIDINE .............................................................................................................................. 969
Summary ......................................................................................................................................... 970

Originators ....................................................................................................................................... 970
Clinical Data: .................................................................................................................................... 970
346) LOMITAPIDE ............................................................................................................................ 972
Summary ......................................................................................................................................... 972

Originators ....................................................................................................................................... 972
Clinical Data: .................................................................................................................................... 972
347) LONAFARNIB ............................................................................................................................ 974
Summary ......................................................................................................................................... 975

Originators ....................................................................................................................................... 975

Clinical Data: .................................................................................................................................... 975
348) LOSIGAMONE .......................................................................................................................... 977
Summary ......................................................................................................................................... 977

Originators ....................................................................................................................................... 977
Clinical Data: .................................................................................................................................... 978
349) LU-AA21004 ............................................................................................................................. 980
Summary ......................................................................................................................................... 980

Originators ....................................................................................................................................... 980
Clinical Data: .................................................................................................................................... 980
350) LUBIPROSTONE ........................................................................................................................ 982
Summary ......................................................................................................................................... 982

Originators ....................................................................................................................................... 982
Clinical Data: .................................................................................................................................... 983
351) LURASIDONE ............................................................................................................................ 985
Summary ......................................................................................................................................... 985

Originators ....................................................................................................................................... 985
Clinical Data: .................................................................................................................................... 985
352) LUSUPULTIDE........................................................................................................................... 987
Summary ......................................................................................................................................... 987

Originators ....................................................................................................................................... 988
Clinical Data: .................................................................................................................................... 988
353) LX-201 ...................................................................................................................................... 990
Summary ......................................................................................................................................... 990

Originators ....................................................................................................................................... 990
Clinical Data: .................................................................................................................................... 990

354) LY-544344 ................................................................................................................................ 992
Summary ......................................................................................................................................... 992

Originators ....................................................................................................................................... 993
Clinical Data: .................................................................................................................................... 993
355) LYMPHATIC TARGETING AGENT .............................................................................................. 995
Summary ......................................................................................................................................... 995

Originators ....................................................................................................................................... 995
Clinical Data: .................................................................................................................................... 995
356) LYMPHOSCAN .......................................................................................................................... 997
Summary ......................................................................................................................................... 998

Originators ....................................................................................................................................... 998
Clinical Data: .................................................................................................................................... 998
357) MAGE-A3 ANTIGEN-SPECIFIC CANCER .................................................................................. 1000
Summary ....................................................................................................................................... 1000

Originators ..................................................................................................................................... 1000
Licensing and General info: ........................................................................................................... 1000
Clinical Data: .................................................................................................................................. 1000
358) MASILUKAST .......................................................................................................................... 1002
Summary ....................................................................................................................................... 1003

Originators ..................................................................................................................................... 1003
Clinical Data: .................................................................................................................................. 1003
359) MASITINIB .............................................................................................................................. 1005
Summary ....................................................................................................................................... 1005

Originators ..................................................................................................................................... 1005
Clinical Data: .................................................................................................................................. 1006
360) MBX-102 ................................................................................................................................ 1008
Summary ....................................................................................................................................... 1008

Originators ..................................................................................................................................... 1008
Clinical Data: .................................................................................................................................. 1008
361) MC-1 ...................................................................................................................................... 1010
Summary ....................................................................................................................................... 1010

Originators ..................................................................................................................................... 1010
Clinical Data: .................................................................................................................................. 1011
362) MDI-403 ................................................................................................................................. 1013
Summary ....................................................................................................................................... 1013

Originators ..................................................................................................................................... 1013
Clinical Data: .................................................................................................................................. 1013
363) MDV-3100 ............................................................................................................................. 1015
Summary ....................................................................................................................................... 1015

Originators ..................................................................................................................................... 1016
Clinical Data: .................................................................................................................................. 1016
364) MDX-1379 .............................................................................................................................. 1018
Summary ....................................................................................................................................... 1018

Originators ..................................................................................................................................... 1018
Clinical Data: .................................................................................................................................. 1018
365) MECLORETHAMINE ............................................................................................................... 1020
Summary ....................................................................................................................................... 1020

Originators ..................................................................................................................................... 1021
Clinical Data: .................................................................................................................................. 1021
366) MEDIDUR ............................................................................................................................... 1023
Summary ....................................................................................................................................... 1023

Originators ..................................................................................................................................... 1023

Clinical Data: .................................................................................................................................. 1023
367) MELANOMA VACCINE (NEW YORK UNIVERSITY) .................................................................. 1025
Summary ....................................................................................................................................... 1026

Originators ..................................................................................................................................... 1026
Clinical Data: .................................................................................................................................. 1026
368) MEMANTINE HYDROCHLORIDE ............................................................................................. 1028
Summary ....................................................................................................................................... 1028

Originators ..................................................................................................................................... 1028
Clinical Data: .................................................................................................................................. 1028
369) MENINGOCOCCAL VACCINE .................................................................................................. 1030
Summary ....................................................................................................................................... 1031

Originators ..................................................................................................................................... 1031
Clinical Data: .................................................................................................................................. 1031
370) MESALAMINE......................................................................................................................... 1033
Summary ....................................................................................................................................... 1033

Originators ..................................................................................................................................... 1033
Clinical Data: .................................................................................................................................. 1034
371) MESENCHYMAL STEM CELL THERAPY ................................................................................... 1036
Summary ....................................................................................................................................... 1036

Originators ..................................................................................................................................... 1036
Clinical Data: .................................................................................................................................. 1036
372) MICONAZOLE NITRATE .......................................................................................................... 1038
Summary ....................................................................................................................................... 1038

Originators ..................................................................................................................................... 1038
Clinical Data: .................................................................................................................................. 1039
373) MIDAZOLAM (INTRANASAL), INTRANASAL ........................................................................... 1041

Summary ....................................................................................................................................... 1041
Originators ..................................................................................................................................... 1041
Clinical Data: .................................................................................................................................. 1041
374) MIDGE IMMUNOMODULATOR ............................................................................................. 1043
Summary ....................................................................................................................................... 1043

Originators ..................................................................................................................................... 1044
Clinical Data: .................................................................................................................................. 1044
375) MIFEPRISTONE....................................................................................................................... 1046
Summary ....................................................................................................................................... 1046

Originators ..................................................................................................................................... 1046
Clinical Data: .................................................................................................................................. 1046
376) MIPOMERSEN SODIUM ......................................................................................................... 1048
Summary ....................................................................................................................................... 1048

Originators ..................................................................................................................................... 1049
Clinical Data: .................................................................................................................................. 1049
377) MITGLINIDE + METFORMIN ................................................................................................... 1051
Summary ....................................................................................................................................... 1051

Originators ..................................................................................................................................... 1051
Clinical Data: .................................................................................................................................. 1051
378) MITIGLINIDE CALCIUM HYDRATE .......................................................................................... 1053
Summary ....................................................................................................................................... 1054

Originators ..................................................................................................................................... 1054
Clinical Data: .................................................................................................................................. 1054
379) MK-677 .................................................................................................................................. 1056
Summary ....................................................................................................................................... 1056

Originators ..................................................................................................................................... 1056

Clinical Data: .................................................................................................................................. 1056
380) MN-001.................................................................................................................................. 1058
Summary ....................................................................................................................................... 1059

Originators ..................................................................................................................................... 1059
Clinical Data: .................................................................................................................................. 1059
381) MN-305.................................................................................................................................. 1061
Summary ....................................................................................................................................... 1061

Originators ..................................................................................................................................... 1061
Clinical Data: .................................................................................................................................. 1062
382) MORPHINE + OXYCODONE .................................................................................................... 1064
Summary ....................................................................................................................................... 1064

Originators ..................................................................................................................................... 1064
Clinical Data: .................................................................................................................................. 1064
383) MORPHINE SULFATE .............................................................................................................. 1066
Summary ....................................................................................................................................... 1066

Originators ..................................................................................................................................... 1066
Clinical Data: .................................................................................................................................. 1067
384) MOXIFLOXACIN...................................................................................................................... 1069
Summary ....................................................................................................................................... 1069

Originators ..................................................................................................................................... 1069
Clinical Data: .................................................................................................................................. 1069
385) MPC-6827 .............................................................................................................................. 1071
Summary ....................................................................................................................................... 1071

Originators ..................................................................................................................................... 1072
Clinical Data: .................................................................................................................................. 1072

386) MPL-CONTAINING POLLINEX ALLERGY .................................................................................. 1074
Summary ....................................................................................................................................... 1074

Originators ..................................................................................................................................... 1074
Clinical Data: .................................................................................................................................. 1074
387) MQX-503 ............................................................................................................................... 1076
Summary ....................................................................................................................................... 1076

Originators ..................................................................................................................................... 1077
Clinical Data: .................................................................................................................................. 1077
388) MRX-1024 .............................................................................................................................. 1079
Summary ....................................................................................................................................... 1079

Originators ..................................................................................................................................... 1079
Clinical Data: .................................................................................................................................. 1079
389) MYCOBACTERIAL CELL WALL-DNA COMPLEX ....................................................................... 1081
Summary ....................................................................................................................................... 1082

Originators ..................................................................................................................................... 1082
Clinical Data: .................................................................................................................................. 1082
390) MYCOPHENOLATE MOFETIL .................................................................................................. 1084
Summary ....................................................................................................................................... 1084

Originators ..................................................................................................................................... 1084
Clinical Data: .................................................................................................................................. 1084
391) NALMEFENE ........................................................................................................................... 1086
Summary ....................................................................................................................................... 1087

Originators ..................................................................................................................................... 1087
Clinical Data: .................................................................................................................................. 1087
392) NEMORUBICIN ....................................................................................................................... 1089
Summary ....................................................................................................................................... 1089

Originators ..................................................................................................................................... 1089
Clinical Data: .................................................................................................................................. 1090
393) NERAMEXANE ........................................................................................................................ 1092
Summary ....................................................................................................................................... 1092

Originators ..................................................................................................................................... 1092
Clinical Data: .................................................................................................................................. 1092
394) NERVE REGENERATION TEMPLATES ..................................................................................... 1094
Summary ....................................................................................................................................... 1094

Originators ..................................................................................................................................... 1094
Clinical Data: .................................................................................................................................. 1095
395) NESTORONE + ESTRADIOL GEL .............................................................................................. 1097
Summary ....................................................................................................................................... 1097

Originators ..................................................................................................................................... 1097
Clinical Data: .................................................................................................................................. 1097
396) NICVAX................................................................................................................................... 1099
Summary ....................................................................................................................................... 1099

Originators ..................................................................................................................................... 1100
Clinical Data: .................................................................................................................................. 1100
397) NIMOTUZUMAB .................................................................................................................... 1102
Summary ....................................................................................................................................... 1102

Originators ..................................................................................................................................... 1102
Clinical Data: .................................................................................................................................. 1102
398) NOFERTIL ............................................................................................................................... 1104
Summary ....................................................................................................................................... 1104

Originators ..................................................................................................................................... 1105

Clinical Data: .................................................................................................................................. 1105
399) NOLOMIROLE......................................................................................................................... 1107
Summary ....................................................................................................................................... 1107

Originators ..................................................................................................................................... 1107
Clinical Data: .................................................................................................................................. 1107
400) NOV-002 ................................................................................................................................ 1109
Summary ....................................................................................................................................... 1110

Originators ..................................................................................................................................... 1110
Clinical Data: .................................................................................................................................. 1110
401) NS-126 ................................................................................................................................... 1112
Summary ....................................................................................................................................... 1112

Originators ..................................................................................................................................... 1112
Clinical Data: .................................................................................................................................. 1112
402) NT-501 ................................................................................................................................... 1114
Summary ....................................................................................................................................... 1115

Originators ..................................................................................................................................... 1115
Clinical Data: .................................................................................................................................. 1115
403) NUMAX .................................................................................................................................. 1117
Summary ....................................................................................................................................... 1117

Originators ..................................................................................................................................... 1117
Clinical Data: .................................................................................................................................. 1118
404) NWP-06 ................................................................................................................................. 1120
Summary ....................................................................................................................................... 1120

Originators ..................................................................................................................................... 1120
Clinical Data: .................................................................................................................................. 1120
405) NX-1207 ................................................................................................................................. 1122

Summary ....................................................................................................................................... 1122
Originators ..................................................................................................................................... 1122
Clinical Data: .................................................................................................................................. 1123
406) OCTAFLUOROPROPANE......................................................................................................... 1125
Summary ....................................................................................................................................... 1125

Originators ..................................................................................................................................... 1125
Clinical Data: .................................................................................................................................. 1125
407) OCTREOTIDE .......................................................................................................................... 1127
Summary ....................................................................................................................................... 1127

Originators ..................................................................................................................................... 1128
Clinical Data: .................................................................................................................................. 1128
408) OCTREOTIDE SUSTAINED RELEASE IMPLANT ........................................................................ 1130
Summary ....................................................................................................................................... 1130

Originators ..................................................................................................................................... 1130
Clinical Data: .................................................................................................................................. 1130
409) ODANACATIB ......................................................................................................................... 1132
Summary ....................................................................................................................................... 1132

Originators ..................................................................................................................................... 1133
Clinical Data: .................................................................................................................................. 1133
410) OGX-011 ................................................................................................................................ 1135
Summary ....................................................................................................................................... 1135

Originators ..................................................................................................................................... 1135
Clinical Data: .................................................................................................................................. 1135
411) OMACOR................................................................................................................................ 1137
Summary ....................................................................................................................................... 1138

Originators ..................................................................................................................................... 1138

Clinical Data: .................................................................................................................................. 1138
412) OMALIZUMAB........................................................................................................................ 1140
Summary ....................................................................................................................................... 1140

Originators ..................................................................................................................................... 1140
Clinical Data: .................................................................................................................................. 1140
413) OMEPRAZOLE ........................................................................................................................ 1142
Summary ....................................................................................................................................... 1143

Originators ..................................................................................................................................... 1143
Clinical Data: .................................................................................................................................. 1143
414) OMIGANAN............................................................................................................................ 1145
Summary ....................................................................................................................................... 1145

Originators ..................................................................................................................................... 1145
Clinical Data: .................................................................................................................................. 1146
415) OMS-103HP ........................................................................................................................... 1148
Summary ....................................................................................................................................... 1148

Originators ..................................................................................................................................... 1148
Clinical Data: .................................................................................................................................. 1148
416) ONCOVAX .............................................................................................................................. 1150
Summary ....................................................................................................................................... 1150

Originators ..................................................................................................................................... 1150
Clinical Data: .................................................................................................................................. 1151
417) ONCOVEX GM-CSF ................................................................................................................. 1153
Summary ....................................................................................................................................... 1153

Originators ..................................................................................................................................... 1153
Clinical Data: .................................................................................................................................. 1153

418) ONDANSETRON ..................................................................................................................... 1155
Summary ....................................................................................................................................... 1155

Originators ..................................................................................................................................... 1156
Clinical Data: .................................................................................................................................. 1156
419) ONO-2506 .............................................................................................................................. 1158
Summary ....................................................................................................................................... 1158

Originators ..................................................................................................................................... 1158
Clinical Data: .................................................................................................................................. 1158
420) OPC-31260 ............................................................................................................................. 1160
Summary ....................................................................................................................................... 1160

Originators ..................................................................................................................................... 1161
Clinical Data: .................................................................................................................................. 1161
421) OPEBACAN ............................................................................................................................. 1163
Summary ....................................................................................................................................... 1163

Originators ..................................................................................................................................... 1163
Clinical Data: .................................................................................................................................. 1163
422) ORAL ACYCLOVIR ................................................................................................................... 1165
Summary ....................................................................................................................................... 1166

Originators ..................................................................................................................................... 1166
Clinical Data: .................................................................................................................................. 1166
423) ORAL CYSTEINE ...................................................................................................................... 1168
Summary ....................................................................................................................................... 1168

Originators ..................................................................................................................................... 1168
Clinical Data: .................................................................................................................................. 1168
424) ORAL FLUPIRTINE .................................................................................................................. 1170
Summary ....................................................................................................................................... 1171

Originators ..................................................................................................................................... 1171
Clinical Data: .................................................................................................................................. 1171
425) ORAL SALMON CALCITONIN .................................................................................................. 1173
Summary ....................................................................................................................................... 1173

Originators ..................................................................................................................................... 1173
Clinical Data: .................................................................................................................................. 1174
426) ORAL TREPROSTINIL .............................................................................................................. 1176
Summary ....................................................................................................................................... 1176

Originators ..................................................................................................................................... 1176
Clinical Data: .................................................................................................................................. 1176
427) ORG-32818 ............................................................................................................................ 1178
Summary ....................................................................................................................................... 1178

Originators ..................................................................................................................................... 1178
Clinical Data: .................................................................................................................................. 1179
428) ORG-50081 ............................................................................................................................ 1181
Summary ....................................................................................................................................... 1181

Originators ..................................................................................................................................... 1181
Clinical Data: .................................................................................................................................. 1181
429) OSI-906 .................................................................................................................................. 1183
Summary ....................................................................................................................................... 1183

Originators ..................................................................................................................................... 1184
Clinical Data: .................................................................................................................................. 1184
430) OSPEMIFENE .......................................................................................................................... 1186
Summary ....................................................................................................................................... 1186

Originators ..................................................................................................................................... 1186

Clinical Data: .................................................................................................................................. 1186
431) OTELIXIZUMAB ...................................................................................................................... 1188
Summary ....................................................................................................................................... 1188

Originators ..................................................................................................................................... 1189
Clinical Data: .................................................................................................................................. 1189
432) OXCARBAZEPINE .................................................................................................................... 1191
Summary ....................................................................................................................................... 1191

Originators ..................................................................................................................................... 1191
Clinical Data: .................................................................................................................................. 1191
433) OXYCODONE + NALOXONE .................................................................................................... 1193
Summary ....................................................................................................................................... 1194

Originators ..................................................................................................................................... 1194
Clinical Data: .................................................................................................................................. 1194
434) OXYCODONE + NALTREXONE ................................................................................................ 1196
Summary ....................................................................................................................................... 1196

Originators ..................................................................................................................................... 1196
Clinical Data: .................................................................................................................................. 1197
435) OZAGREL SODIUM ................................................................................................................. 1199
Summary ....................................................................................................................................... 1199

Originators ..................................................................................................................................... 1199
Clinical Data: .................................................................................................................................. 1199
436) PACLITAXEL ............................................................................................................................ 1201
Summary ....................................................................................................................................... 1201

Originators ..................................................................................................................................... 1202
Clinical Data: .................................................................................................................................. 1202
437) PACLITAXEL NP ...................................................................................................................... 1204

Summary ....................................................................................................................................... 1204
Originators ..................................................................................................................................... 1204
Clinical Data: .................................................................................................................................. 1204
438) PACLITAXEL POLIGLUMEX ..................................................................................................... 1206
Summary ....................................................................................................................................... 1207

Originators ..................................................................................................................................... 1207
Clinical Data: .................................................................................................................................. 1207
439) PALIFOSFAMIDE..................................................................................................................... 1209
Summary ....................................................................................................................................... 1209

Originators ..................................................................................................................................... 1209
Clinical Data: .................................................................................................................................. 1210
440) PANCRELIPASE (AMYLASE + LIPASE + PROTEASE) ................................................................. 1212
Summary ....................................................................................................................................... 1212

Originators ..................................................................................................................................... 1212
Clinical Data: .................................................................................................................................. 1212
441) PATUPILONE .......................................................................................................................... 1214
Summary ....................................................................................................................................... 1214

Originators ..................................................................................................................................... 1215
Clinical Data: .................................................................................................................................. 1215
442) PBF-1681................................................................................................................................ 1217
Summary ....................................................................................................................................... 1217

Originators ..................................................................................................................................... 1217
Clinical Data: .................................................................................................................................. 1217
443) PC-515 ................................................................................................................................... 1219
Summary ....................................................................................................................................... 1220

Originators ..................................................................................................................................... 1220

Clinical Data: .................................................................................................................................. 1220
444) PD-02 ..................................................................................................................................... 1222
Summary ....................................................................................................................................... 1222

Originators ..................................................................................................................................... 1222
Clinical Data: .................................................................................................................................. 1223
445) PEGYLATED INTERFERON BETA-1A........................................................................................ 1225
Summary ....................................................................................................................................... 1225

Originators ..................................................................................................................................... 1225
Clinical Data: .................................................................................................................................. 1225
446) PELUBIPROFEN ...................................................................................................................... 1227
Summary ....................................................................................................................................... 1227

Originators ..................................................................................................................................... 1228
Clinical Data: .................................................................................................................................. 1228
447) PENTASTAPH ......................................................................................................................... 1230
Summary ....................................................................................................................................... 1230

Originators ..................................................................................................................................... 1230
Clinical Data: .................................................................................................................................. 1230
448) PERAMPANEL ........................................................................................................................ 1232
Summary ....................................................................................................................................... 1233

Originators ..................................................................................................................................... 1233
Clinical Data: .................................................................................................................................. 1233
449) PERETINOIN ........................................................................................................................... 1235
Summary ....................................................................................................................................... 1235

Originators ..................................................................................................................................... 1235
Clinical Data: .................................................................................................................................. 1236

450) PERFLUBUTANE ..................................................................................................................... 1238
Summary ....................................................................................................................................... 1238

Originators ..................................................................................................................................... 1238
Clinical Data: .................................................................................................................................. 1238
451) PERFOAM............................................................................................................................... 1240
Summary ....................................................................................................................................... 1240

Originators ..................................................................................................................................... 1241
Clinical Data: .................................................................................................................................. 1241
452) PERIFOSINE ............................................................................................................................ 1243
Summary ....................................................................................................................................... 1243

Originators ..................................................................................................................................... 1243
Clinical Data: .................................................................................................................................. 1243
453) PERU-15 PCTB ........................................................................................................................ 1245
Summary ....................................................................................................................................... 1246

Originators ..................................................................................................................................... 1246
Clinical Data: .................................................................................................................................. 1246
454) PEXIGANAN ACETATE ............................................................................................................ 1248
Summary ....................................................................................................................................... 1248

Originators ..................................................................................................................................... 1248
Clinical Data: .................................................................................................................................. 1249
455) PGL-4001 ............................................................................................................................... 1251
Summary ....................................................................................................................................... 1251

Originators ..................................................................................................................................... 1251
Clinical Data: .................................................................................................................................. 1251
456) PHP-HT................................................................................................................................... 1253
Summary ....................................................................................................................................... 1253

Originators ..................................................................................................................................... 1254
Clinical Data: .................................................................................................................................. 1254
457) PICOPLATIN............................................................................................................................ 1256
Summary ....................................................................................................................................... 1256

Originators ..................................................................................................................................... 1256
Clinical Data: .................................................................................................................................. 1256
458) PICOSULPHATE ...................................................................................................................... 1258
Summary ....................................................................................................................................... 1259

Originators ..................................................................................................................................... 1259
Clinical Data: .................................................................................................................................. 1259
459) PIMAVANSERIN TARTRATE .................................................................................................... 1261
Summary ....................................................................................................................................... 1261

Originators ..................................................................................................................................... 1261
Clinical Data: .................................................................................................................................. 1262
460) PIRFENIDONE ......................................................................................................................... 1264
Summary ....................................................................................................................................... 1264

Originators ..................................................................................................................................... 1264
Clinical Data: .................................................................................................................................. 1264
461) PN-401 ................................................................................................................................... 1266
Summary ....................................................................................................................................... 1266

Originators ..................................................................................................................................... 1267
Clinical Data: .................................................................................................................................. 1267
462) POLYCLONAL ANTIBODY STIMULATOR ................................................................................. 1269
Summary ....................................................................................................................................... 1269

Originators ..................................................................................................................................... 1269

Clinical Data: .................................................................................................................................. 1269
463) POVIDONE-IODINE ................................................................................................................ 1271
Summary ....................................................................................................................................... 1272

Originators ..................................................................................................................................... 1272
Clinical Data: .................................................................................................................................. 1272
464) PR1 PEPTIDE VACCINE ........................................................................................................... 1274
Summary ....................................................................................................................................... 1274

Originators ..................................................................................................................................... 1274
Clinical Data: .................................................................................................................................. 1275
465) PRAVASTATIN + FENOFIBRATE .............................................................................................. 1277
Summary ....................................................................................................................................... 1277

Originators ..................................................................................................................................... 1277
Clinical Data: .................................................................................................................................. 1277
466) PREDNISOLONE ..................................................................................................................... 1279
Summary ....................................................................................................................................... 1279

Originators ..................................................................................................................................... 1280
Clinical Data: .................................................................................................................................. 1280
467) PRO-2000 ............................................................................................................................... 1282
Summary ....................................................................................................................................... 1282

Originators ..................................................................................................................................... 1282
Clinical Data: .................................................................................................................................. 1282
468) PROCALYX .............................................................................................................................. 1284
Summary ....................................................................................................................................... 1285

Originators ..................................................................................................................................... 1285
Clinical Data: .................................................................................................................................. 1285
469) PROGESTERONE..................................................................................................................... 1287

Summary ....................................................................................................................................... 1287
Originators ..................................................................................................................................... 1287
Clinical Data: .................................................................................................................................. 1288
470) PROGESTOGEN + ESTROGEN ................................................................................................. 1290
Summary ....................................................................................................................................... 1290

Originators ..................................................................................................................................... 1290
Clinical Data: .................................................................................................................................. 1290
471) PROPOFOL ............................................................................................................................. 1292
Summary ....................................................................................................................................... 1292

Originators ..................................................................................................................................... 1293
Clinical Data: .................................................................................................................................. 1293
472) PROPRANOLOL ...................................................................................................................... 1295
Summary ....................................................................................................................................... 1295

Originators ..................................................................................................................................... 1295
Clinical Data: .................................................................................................................................. 1295
473) PRUCALOPRIDE ...................................................................................................................... 1297
Summary ....................................................................................................................................... 1298

Originators ..................................................................................................................................... 1298
Clinical Data: .................................................................................................................................. 1298
474) PRULIFLOXACIN ..................................................................................................................... 1300
Summary ....................................................................................................................................... 1300

Originators ..................................................................................................................................... 1300
Clinical Data: .................................................................................................................................. 1301
475) PSD-502 ................................................................................................................................. 1303
Summary ....................................................................................................................................... 1303

Originators ..................................................................................................................................... 1303

Clinical Data: .................................................................................................................................. 1303
476) PTK-0796................................................................................................................................ 1305
Summary ....................................................................................................................................... 1305

Originators ..................................................................................................................................... 1306
Clinical Data: .................................................................................................................................. 1306
477) PYRIDOXAMINE ..................................................................................................................... 1308
Summary ....................................................................................................................................... 1308

Originators ..................................................................................................................................... 1308
Clinical Data: .................................................................................................................................. 1308
478) PYRONARIDINE; ARTESUNATE............................................................................................... 1310
Summary ....................................................................................................................................... 1311

Originators ..................................................................................................................................... 1311
Clinical Data: .................................................................................................................................. 1311
479) QS-21 ..................................................................................................................................... 1313
Summary ....................................................................................................................................... 1313

Originators ..................................................................................................................................... 1313
Clinical Data: .................................................................................................................................. 1314
480) QVA-149 ................................................................................................................................ 1316
Summary ....................................................................................................................................... 1316

Originators ..................................................................................................................................... 1316
Clinical Data: .................................................................................................................................. 1316
481) R-HGH .................................................................................................................................... 1318
Summary ....................................................................................................................................... 1318

Originators ..................................................................................................................................... 1319
Clinical Data: .................................................................................................................................. 1319

482) RACOTUMOMAB ................................................................................................................... 1321
Summary ....................................................................................................................................... 1321

Originators ..................................................................................................................................... 1321
Clinical Data: .................................................................................................................................. 1321
483) RAGWEED EXTRACT............................................................................................................... 1323
Summary ....................................................................................................................................... 1324

Originators ..................................................................................................................................... 1324
Clinical Data: .................................................................................................................................. 1324
484) RANPIRNASE .......................................................................................................................... 1326
Summary ....................................................................................................................................... 1326

Originators ..................................................................................................................................... 1326
Clinical Data: .................................................................................................................................. 1327
485) REBAMIPIDE (OPHTHALMIC) ................................................................................................. 1329
Summary ....................................................................................................................................... 1329

Originators ..................................................................................................................................... 1329
Clinical Data: .................................................................................................................................. 1329
486) RECOMBINANT G-CSF............................................................................................................ 1331
Summary ....................................................................................................................................... 1331

Originators ..................................................................................................................................... 1332
Clinical Data: .................................................................................................................................. 1332
487) RECOMBINANT HUMAN MICROPLASMIN ............................................................................. 1334
Summary ....................................................................................................................................... 1334

Originators ..................................................................................................................................... 1334
Clinical Data: .................................................................................................................................. 1334
488) REGORAFENIB........................................................................................................................ 1336
Summary ....................................................................................................................................... 1337

Originators ..................................................................................................................................... 1337
Clinical Data: .................................................................................................................................. 1337
489) RENZAPRIDE .......................................................................................................................... 1339
Summary ....................................................................................................................................... 1339

Originators ..................................................................................................................................... 1339
Clinical Data: .................................................................................................................................. 1340
490) REOLYSIN ............................................................................................................................... 1342
Summary ....................................................................................................................................... 1342

Originators ..................................................................................................................................... 1342
Clinical Data: .................................................................................................................................. 1342
491) RESLIZUMAB .......................................................................................................................... 1344
Summary ....................................................................................................................................... 1344

Originators ..................................................................................................................................... 1345
Clinical Data: .................................................................................................................................. 1345
492) RETASPIMYCIN HYDROCHLORIDE.......................................................................................... 1347
Summary ....................................................................................................................................... 1347

Originators ..................................................................................................................................... 1347
Clinical Data: .................................................................................................................................. 1347
493) RETIGABINE ........................................................................................................................... 1349
Summary ....................................................................................................................................... 1350

Originators ..................................................................................................................................... 1350
Clinical Data: .................................................................................................................................. 1350
494) REUMACON ........................................................................................................................... 1352
Summary ....................................................................................................................................... 1352

Originators ..................................................................................................................................... 1352

Clinical Data: .................................................................................................................................. 1353
495) REVIMMUNE.......................................................................................................................... 1355
Summary ....................................................................................................................................... 1355

Originators ..................................................................................................................................... 1355
Clinical Data: .................................................................................................................................. 1355
496) RG-1068 ................................................................................................................................. 1357
Summary ....................................................................................................................................... 1357

Originators ..................................................................................................................................... 1358
Clinical Data: .................................................................................................................................. 1358
497) RIBAVIRIN .............................................................................................................................. 1360
Summary ....................................................................................................................................... 1360

Originators ..................................................................................................................................... 1360
Clinical Data: .................................................................................................................................. 1360
498) RIDAFOROLIMUS ................................................................................................................... 1362
Summary ....................................................................................................................................... 1363

Originators ..................................................................................................................................... 1363
Clinical Data: .................................................................................................................................. 1363
499) RIFABUTIN + AMOXYCILLIN+ PANTOPRAZOLE ...................................................................... 1365
Summary ....................................................................................................................................... 1365

Originators ..................................................................................................................................... 1365
Clinical Data: .................................................................................................................................. 1366
500) RIFABUTIN + CLARITHROMYCIN + CLOFAZIMINE .................................................................. 1368
Summary ....................................................................................................................................... 1368

Originators ..................................................................................................................................... 1368
Clinical Data: .................................................................................................................................. 1368
501) RIFALAZIL ............................................................................................................................... 1370

Summary ....................................................................................................................................... 1370
Originators ..................................................................................................................................... 1371
Clinical Data: .................................................................................................................................. 1371
502) RIFAMYCIN............................................................................................................................. 1373
Summary ....................................................................................................................................... 1373

Originators ..................................................................................................................................... 1373
Clinical Data: .................................................................................................................................. 1373
503) RIOCIGUAT............................................................................................................................. 1375
Summary ....................................................................................................................................... 1376

Originators ..................................................................................................................................... 1376
Clinical Data: .................................................................................................................................. 1376
504) RIVOGLITAZONE .................................................................................................................... 1378
Summary ....................................................................................................................................... 1378

Originators ..................................................................................................................................... 1378
Clinical Data: .................................................................................................................................. 1379
505) ROFLUMILAST ........................................................................................................................ 1381
Summary ....................................................................................................................................... 1381

Originators ..................................................................................................................................... 1381
Clinical Data: .................................................................................................................................. 1381
506) ROLOFYLLINE ......................................................................................................................... 1383
Summary ....................................................................................................................................... 1383

Originators ..................................................................................................................................... 1384
Clinical Data: .................................................................................................................................. 1384
507) ROSUVASTATIN + ABT-335 .................................................................................................... 1386
Summary ....................................................................................................................................... 1386

Originators ..................................................................................................................................... 1386

Clinical Data: .................................................................................................................................. 1386
508) RUBOXISTAURIN MESYLATE .................................................................................................. 1388
Summary ....................................................................................................................................... 1389

Originators ..................................................................................................................................... 1389
Clinical Data: .................................................................................................................................. 1389
509) RUSALATIDE ACETATE ........................................................................................................... 1391
Summary ....................................................................................................................................... 1391

Originators ..................................................................................................................................... 1391
Clinical Data: .................................................................................................................................. 1392
510) S-102-R .................................................................................................................................. 1394
Summary ....................................................................................................................................... 1394

Originators ..................................................................................................................................... 1394
Clinical Data: .................................................................................................................................. 1394
511) S-18886 .................................................................................................................................. 1396
Summary ....................................................................................................................................... 1396

Originators ..................................................................................................................................... 1397
Clinical Data: .................................................................................................................................. 1397
512) S-303-M ................................................................................................................................. 1399
Summary ....................................................................................................................................... 1399

Originators ..................................................................................................................................... 1399
Clinical Data: .................................................................................................................................. 1399
513) SAFINAMIDE .......................................................................................................................... 1401
Summary ....................................................................................................................................... 1402

Originators ..................................................................................................................................... 1402
Clinical Data: .................................................................................................................................. 1402

514) SAXAGLIPTIN.......................................................................................................................... 1404
Summary ....................................................................................................................................... 1404

Originators ..................................................................................................................................... 1404
Clinical Data: .................................................................................................................................. 1405
515) SENICAPOC ............................................................................................................................ 1407
Summary ....................................................................................................................................... 1407

Originators ..................................................................................................................................... 1407
Clinical Data: .................................................................................................................................. 1407
516) SER-120 .................................................................................................................................. 1409
Summary ....................................................................................................................................... 1409

Originators ..................................................................................................................................... 1410
Clinical Data: .................................................................................................................................. 1410
517) SEVELAMER HYDROCHLORIDE .............................................................................................. 1412
Summary ....................................................................................................................................... 1412

Originators ..................................................................................................................................... 1412
Clinical Data: .................................................................................................................................. 1412
518) SH-U-555-C ............................................................................................................................ 1414
Summary ....................................................................................................................................... 1415

Originators ..................................................................................................................................... 1415
Clinical Data: .................................................................................................................................. 1415
519) SHL-04023.............................................................................................................................. 1417
Summary ....................................................................................................................................... 1417

Originators ..................................................................................................................................... 1417
Clinical Data: .................................................................................................................................. 1418
520) SILODOSIN ............................................................................................................................. 1420
Summary ....................................................................................................................................... 1420

Originators ..................................................................................................................................... 1420
Clinical Data: .................................................................................................................................. 1420
521) SIMPLIRIX ............................................................................................................................... 1422
Summary ....................................................................................................................................... 1422

Originators ..................................................................................................................................... 1423
Clinical Data: .................................................................................................................................. 1423
522) SINUNASE .............................................................................................................................. 1425
Summary ....................................................................................................................................... 1425

Originators ..................................................................................................................................... 1425
Clinical Data: .................................................................................................................................. 1425
523) SITAMAQUINE ....................................................................................................................... 1427
Summary ....................................................................................................................................... 1428

Originators ..................................................................................................................................... 1428
Clinical Data: .................................................................................................................................. 1428
524) SITIMAGENE CERADENOVEC ................................................................................................. 1430
Summary ....................................................................................................................................... 1430

Originators ..................................................................................................................................... 1430
Clinical Data: .................................................................................................................................. 1431
525) SK-1306X................................................................................................................................ 1433
Summary ....................................................................................................................................... 1433

Originators ..................................................................................................................................... 1433
Clinical Data: .................................................................................................................................. 1433
526) SK-3530 .................................................................................................................................. 1435
Summary ....................................................................................................................................... 1435

Originators ..................................................................................................................................... 1436

Clinical Data: .................................................................................................................................. 1436
527) SLV-308 .................................................................................................................................. 1438
Summary ....................................................................................................................................... 1438

Originators ..................................................................................................................................... 1438
Clinical Data: .................................................................................................................................. 1438
528) SODIUM HYALURONATE (TOPICAL OPHTHALMIC USE) ........................................................ 1440
Summary ....................................................................................................................................... 1441

Originators ..................................................................................................................................... 1441
Clinical Data: .................................................................................................................................. 1441
529) SODIUM OXYBATE ................................................................................................................. 1443
Summary ....................................................................................................................................... 1443

Originators ..................................................................................................................................... 1443
Clinical Data: .................................................................................................................................. 1444
530) SOH-075 ................................................................................................................................. 1446
Summary ....................................................................................................................................... 1446

Originators ..................................................................................................................................... 1446
Clinical Data: .................................................................................................................................. 1446
531) SOLUBLE BETA-1,3/1,6 GLUCAN ............................................................................................ 1448
Summary ....................................................................................................................................... 1448

Originators ..................................................................................................................................... 1449
Clinical Data: .................................................................................................................................. 1449
532) SQUALAMINE......................................................................................................................... 1451
Summary ....................................................................................................................................... 1451

Originators ..................................................................................................................................... 1451
Clinical Data: .................................................................................................................................. 1451
533) SR-121463.............................................................................................................................. 1453

Summary ....................................................................................................................................... 1454
Originators ..................................................................................................................................... 1454
Clinical Data: .................................................................................................................................. 1454
534) SR-58611................................................................................................................................ 1456
Summary ....................................................................................................................................... 1456

Originators ..................................................................................................................................... 1456
Clinical Data: .................................................................................................................................. 1457
535) SSR-591813 ............................................................................................................................ 1459
Summary ....................................................................................................................................... 1459

Originators ..................................................................................................................................... 1459
Clinical Data: .................................................................................................................................. 1459
536) STANNSOPORFIN ................................................................................................................... 1461
Summary ....................................................................................................................................... 1461

Originators ..................................................................................................................................... 1462
Clinical Data: .................................................................................................................................. 1462
537) STREPTORIX ........................................................................................................................... 1464
Summary ....................................................................................................................................... 1464

Originators ..................................................................................................................................... 1464
Clinical Data: .................................................................................................................................. 1464
538) SUBSTANCE P ANTAGONISTS (MERCK) ................................................................................. 1466
Summary ....................................................................................................................................... 1467

Originators ..................................................................................................................................... 1467
Clinical Data: .................................................................................................................................. 1467
539) SUCCINOBUCOL ..................................................................................................................... 1469
Summary ....................................................................................................................................... 1469

Originators ..................................................................................................................................... 1469

Clinical Data: .................................................................................................................................. 1470
540) SUFENTANIL IMPLANT ........................................................................................................... 1472
Summary ....................................................................................................................................... 1472

Originators ..................................................................................................................................... 1472
Clinical Data: .................................................................................................................................. 1472
541) SUMATRIPTAN (NEEDLELESS DELIVERY, INTRAJECT) ............................................................ 1474
Summary ....................................................................................................................................... 1474

Originators ..................................................................................................................................... 1475
Clinical Data: .................................................................................................................................. 1475
542) SUMATRIPTAN (SUBLINGUAL, MIGRAINE) ............................................................................ 1477
Summary ....................................................................................................................................... 1477

Originators ..................................................................................................................................... 1477
Clinical Data: .................................................................................................................................. 1477
543) SUSTAINED RELEASE RECOMBINANT HUMAN GROWTH...................................................... 1479
Summary ....................................................................................................................................... 1480

Originators ..................................................................................................................................... 1480
Clinical Data: .................................................................................................................................. 1480
544) T4N5 LIPOSOME LOTION ....................................................................................................... 1482
Summary ....................................................................................................................................... 1482

Originators ..................................................................................................................................... 1482
Clinical Data: .................................................................................................................................. 1483
545) TACI-IG ................................................................................................................................... 1485
Summary ....................................................................................................................................... 1485

Originators ..................................................................................................................................... 1485
Clinical Data: .................................................................................................................................. 1485

546) TACROLIMUS ......................................................................................................................... 1487
Summary ....................................................................................................................................... 1487

Originators ..................................................................................................................................... 1488
Clinical Data: .................................................................................................................................. 1488
547) TAFAMIDIS ............................................................................................................................. 1490
Summary ....................................................................................................................................... 1490

Originators ..................................................................................................................................... 1490
Clinical Data: .................................................................................................................................. 1490
548) TAFENOQUINE ....................................................................................................................... 1492
Summary ....................................................................................................................................... 1493

Originators ..................................................................................................................................... 1493
Clinical Data: .................................................................................................................................. 1493
549) TAGATOSE ............................................................................................................................. 1495
Summary ....................................................................................................................................... 1495

Originators ..................................................................................................................................... 1495
Clinical Data: .................................................................................................................................. 1496
550) TAK-242 ................................................................................................................................. 1498
Summary ....................................................................................................................................... 1498

Originators ..................................................................................................................................... 1498
Clinical Data: .................................................................................................................................. 1498
551) TALACTOFERRIN .................................................................................................................... 1500
Summary ....................................................................................................................................... 1500

Originators ..................................................................................................................................... 1501
Clinical Data: .................................................................................................................................. 1501
552) TALIGLUCERASE ALFA ............................................................................................................ 1503
Summary ....................................................................................................................................... 1503

Originators ..................................................................................................................................... 1503
Clinical Data: .................................................................................................................................. 1503
553) TANESPIMYCIN ...................................................................................................................... 1505
Summary ....................................................................................................................................... 1506

Originators ..................................................................................................................................... 1506
Clinical Data: .................................................................................................................................. 1506
554) TAPENTADOL ......................................................................................................................... 1508
Summary ....................................................................................................................................... 1508

Originators ..................................................................................................................................... 1508
Clinical Data: .................................................................................................................................. 1509
555) TARIBAVIRIN .......................................................................................................................... 1511
Summary ....................................................................................................................................... 1511

Originators ..................................................................................................................................... 1511
Clinical Data: .................................................................................................................................. 1511
556) TASIMELTEON........................................................................................................................ 1513
Summary ....................................................................................................................................... 1513

Originators ..................................................................................................................................... 1514
Clinical Data: .................................................................................................................................. 1514
557) TASPOGLUTIDE ...................................................................................................................... 1516
Summary ....................................................................................................................................... 1516

Originators ..................................................................................................................................... 1516
Clinical Data: .................................................................................................................................. 1516
558) TECADENOSON ...................................................................................................................... 1518
Summary ....................................................................................................................................... 1519

Originators ..................................................................................................................................... 1519

Clinical Data: .................................................................................................................................. 1519
559) TECTIN ................................................................................................................................... 1521
Summary ....................................................................................................................................... 1521

Originators ..................................................................................................................................... 1521
Clinical Data: .................................................................................................................................. 1522
560) TEDUGLUTIDE ........................................................................................................................ 1524
Summary ....................................................................................................................................... 1524

Originators ..................................................................................................................................... 1524
Clinical Data: .................................................................................................................................. 1524
561) TELAPREVIR ........................................................................................................................... 1526
Summary ....................................................................................................................................... 1526

Originators ..................................................................................................................................... 1527
Clinical Data: .................................................................................................................................. 1527
562) TENOFOVIR (VAGINAL GEL) ................................................................................................... 1529
Summary ....................................................................................................................................... 1529

Originators ..................................................................................................................................... 1529
Clinical Data: .................................................................................................................................. 1529
563) TEPLIZUMAB .......................................................................................................................... 1531
Summary ....................................................................................................................................... 1532

Originators ..................................................................................................................................... 1532
Clinical Data: .................................................................................................................................. 1532
564) TERBINAFINE (TOPICAL) ........................................................................................................ 1534
Summary ....................................................................................................................................... 1534

Originators ..................................................................................................................................... 1534
Clinical Data: .................................................................................................................................. 1535
565) TERIFLUNOMIDE .................................................................................................................... 1537

Summary ....................................................................................................................................... 1537
Originators ..................................................................................................................................... 1537
Clinical Data: .................................................................................................................................. 1537
566) TERLIPRESSIN ......................................................................................................................... 1539
Summary ....................................................................................................................................... 1539

Originators ..................................................................................................................................... 1540
Clinical Data: .................................................................................................................................. 1540
567) TESAMORELIN ....................................................................................................................... 1542
Summary ....................................................................................................................................... 1542

Originators ..................................................................................................................................... 1542
Clinical Data: .................................................................................................................................. 1542
568) TESMILIFENE .......................................................................................................................... 1544
Summary ....................................................................................................................................... 1545

Originators ..................................................................................................................................... 1545
Clinical Data: .................................................................................................................................. 1545
569) TESTOSTERONE...................................................................................................................... 1547
Summary ....................................................................................................................................... 1547

Originators ..................................................................................................................................... 1547
Clinical Data: .................................................................................................................................. 1548
570) TESTOSTERONE + ESTRADIOL GEL ......................................................................................... 1550
Summary ....................................................................................................................................... 1550

Originators ..................................................................................................................................... 1550
Clinical Data: .................................................................................................................................. 1550
571) TESTOSTERONE GEL............................................................................................................... 1552
Summary ....................................................................................................................................... 1552

Originators ..................................................................................................................................... 1553

Clinical Data: .................................................................................................................................. 1553
572) TETOMILAST .......................................................................................................................... 1555
Summary ....................................................................................................................................... 1555

Originators ..................................................................................................................................... 1555
Clinical Data: .................................................................................................................................. 1555
573) TEZOSENTAN ......................................................................................................................... 1557
Summary ....................................................................................................................................... 1558

Originators ..................................................................................................................................... 1558
Clinical Data: .................................................................................................................................. 1558
574) THC + CBD .............................................................................................................................. 1560
Summary ....................................................................................................................................... 1560

Originators ..................................................................................................................................... 1560
Clinical Data: .................................................................................................................................. 1561
575) THERACLEC LIPASE ................................................................................................................ 1563
Summary ....................................................................................................................................... 1563

Originators ..................................................................................................................................... 1563
Clinical Data: .................................................................................................................................. 1563
576) THROMBIN RECEPTOR ANTAGONIST .................................................................................... 1565
Summary ....................................................................................................................................... 1565

Originators ..................................................................................................................................... 1566
Clinical Data: .................................................................................................................................. 1566
577) THYMALFASIN........................................................................................................................ 1568
Summary ....................................................................................................................................... 1568

Originators ..................................................................................................................................... 1568
Clinical Data: .................................................................................................................................. 1568

578) THYMIDINE KINASE EXPRESSING DONOR T CELLS ................................................................ 1570
Summary ....................................................................................................................................... 1571

Originators ..................................................................................................................................... 1571
Clinical Data: .................................................................................................................................. 1571
579) TIFACOGIN ............................................................................................................................. 1573
Summary ....................................................................................................................................... 1573

Originators ..................................................................................................................................... 1573
Clinical Data: .................................................................................................................................. 1574
580) TILARGININE ACETATE ........................................................................................................... 1576
Summary ....................................................................................................................................... 1576

Originators ..................................................................................................................................... 1576
Clinical Data: .................................................................................................................................. 1576
581) TIOPRONIN ............................................................................................................................ 1578
Summary ....................................................................................................................................... 1578

Originators ..................................................................................................................................... 1579
Clinical Data: .................................................................................................................................. 1579
582) TIPIFARNIB ............................................................................................................................. 1581
Summary ....................................................................................................................................... 1581

Originators ..................................................................................................................................... 1581
Clinical Data: .................................................................................................................................. 1581
583) TIRAPAZAMINE ...................................................................................................................... 1583
Summary ....................................................................................................................................... 1584

Originators ..................................................................................................................................... 1584
Clinical Data: .................................................................................................................................. 1584
584) TIVOZANIB ............................................................................................................................. 1586
Summary ....................................................................................................................................... 1586

Originators ..................................................................................................................................... 1586
Clinical Data: .................................................................................................................................. 1587
585) TLT THERAPY.......................................................................................................................... 1589
Summary ....................................................................................................................................... 1589

Originators ..................................................................................................................................... 1589
Clinical Data: .................................................................................................................................. 1589
586) TM INJECTION SOLUTION ...................................................................................................... 1591
Summary ....................................................................................................................................... 1591

Originators ..................................................................................................................................... 1592
Clinical Data: .................................................................................................................................. 1592
587) TMC-278 + TRUVADA ............................................................................................................ 1594
Summary ....................................................................................................................................... 1594

Originators ..................................................................................................................................... 1594
Clinical Data: .................................................................................................................................. 1594
588) TNF ALPHA RECEPTOR-FC ...................................................................................................... 1596
Summary ....................................................................................................................................... 1597

Originators ..................................................................................................................................... 1597
Clinical Data: .................................................................................................................................. 1597
589) TOBRAMYCIN (INHALED) ....................................................................................................... 1599
Summary ....................................................................................................................................... 1599

Originators ..................................................................................................................................... 1599
Clinical Data: .................................................................................................................................. 1600
590) TOLEVAMER........................................................................................................................... 1602
Summary ....................................................................................................................................... 1602

Originators ..................................................................................................................................... 1602

Clinical Data: .................................................................................................................................. 1602
591) TOPICAL CROMOLYN SODIUM .............................................................................................. 1604
Summary ....................................................................................................................................... 1604

Originators ..................................................................................................................................... 1605
Clinical Data: .................................................................................................................................. 1605
592) TOREMIFENE.......................................................................................................................... 1607
Summary ....................................................................................................................................... 1607

Originators ..................................................................................................................................... 1607
Clinical Data: .................................................................................................................................. 1607
593) TOREZOLID............................................................................................................................. 1609
Summary ....................................................................................................................................... 1610

Originators ..................................................................................................................................... 1610
Clinical Data: .................................................................................................................................. 1610
594) TORSEMIDE ER....................................................................................................................... 1612
Summary ....................................................................................................................................... 1612

Originators ..................................................................................................................................... 1612
Clinical Data: .................................................................................................................................. 1613
595) TRAMIPROSATE ..................................................................................................................... 1615
Summary ....................................................................................................................................... 1615

Originators ..................................................................................................................................... 1615
Clinical Data: .................................................................................................................................. 1615
596) TRANSCUTANEOUS IMMUNIZATION PATCH (DIARRHEA) .................................................... 1617
Summary ....................................................................................................................................... 1617

Originators ..................................................................................................................................... 1618
Clinical Data: .................................................................................................................................. 1618
597) TRANSDERMAL KETOPROFEN ............................................................................................... 1620

Summary ....................................................................................................................................... 1620
Originators ..................................................................................................................................... 1620
Clinical Data: .................................................................................................................................. 1620
598) TRANSMUCOSAL (BEMA) FENTANYL ..................................................................................... 1622
Summary ....................................................................................................................................... 1623

Originators ..................................................................................................................................... 1623
Clinical Data: .................................................................................................................................. 1623
599) TREMELIMUMAB ................................................................................................................... 1625
Summary ....................................................................................................................................... 1625

Originators ..................................................................................................................................... 1625
Clinical Data: .................................................................................................................................. 1626
600) TRIAMCINOLONE ACETONIDE (EYE DISEASES) ...................................................................... 1628
Summary ....................................................................................................................................... 1628

Originators ..................................................................................................................................... 1628
Clinical Data: .................................................................................................................................. 1628
601) TRIMEGESTONE ..................................................................................................................... 1630
Summary ....................................................................................................................................... 1630

Originators ..................................................................................................................................... 1631
Clinical Data: .................................................................................................................................. 1631
602) TRIMEGESTONE-ESTRADIOL PATCH ...................................................................................... 1633
Summary ....................................................................................................................................... 1633

Originators ..................................................................................................................................... 1633
Clinical Data: .................................................................................................................................. 1633
603) TRIOXOLANE .......................................................................................................................... 1635
Summary ....................................................................................................................................... 1636

Originators ..................................................................................................................................... 1636

Clinical Data: .................................................................................................................................. 1636
604) TRIOXOLANE DERIVATE ......................................................................................................... 1638
Summary ....................................................................................................................................... 1638

Originators ..................................................................................................................................... 1638
Clinical Data: .................................................................................................................................. 1639
605) TRIPLE HORMONE THERAPY ORAL CONTRACEPTIVE ............................................................ 1641
Summary ....................................................................................................................................... 1641

Originators ..................................................................................................................................... 1641
Clinical Data: .................................................................................................................................. 1641
606) TRK-820 ................................................................................................................................. 1643
Summary ....................................................................................................................................... 1643

Originators ..................................................................................................................................... 1644
Clinical Data: .................................................................................................................................. 1644
607) TROVAX.................................................................................................................................. 1646
Summary ....................................................................................................................................... 1646

Originators ..................................................................................................................................... 1646
Clinical Data: .................................................................................................................................. 1646
608) TROXACITABINE ..................................................................................................................... 1648
Summary ....................................................................................................................................... 1649

Originators ..................................................................................................................................... 1649
Clinical Data: .................................................................................................................................. 1649
609) UDENAFIL............................................................................................................................... 1651
Summary ....................................................................................................................................... 1651

Originators ..................................................................................................................................... 1651
Clinical Data: .................................................................................................................................. 1652

610) ULTRA-PURE EPA ................................................................................................................... 1654
Summary ....................................................................................................................................... 1654

Originators ..................................................................................................................................... 1654
Clinical Data: .................................................................................................................................. 1654
611) UNFRACTIONATED HEPARIN ................................................................................................. 1656
Summary ....................................................................................................................................... 1656

Originators ..................................................................................................................................... 1657
Clinical Data: .................................................................................................................................. 1657
612) USHERCELL............................................................................................................................. 1659
Summary ....................................................................................................................................... 1659

Originators ..................................................................................................................................... 1659
Clinical Data: .................................................................................................................................. 1659
613) V-1512 ................................................................................................................................... 1661
Summary ....................................................................................................................................... 1662

Originators ..................................................................................................................................... 1662
Clinical Data: .................................................................................................................................. 1662
614) VALSPODAR ........................................................................................................................... 1664
Summary ....................................................................................................................................... 1664

Originators ..................................................................................................................................... 1664
Clinical Data: .................................................................................................................................. 1665
615) VAPREOTIDE ACETATE ........................................................................................................... 1667
Summary ....................................................................................................................................... 1667

Originators ..................................................................................................................................... 1667
Clinical Data: .................................................................................................................................. 1667
616) VARESPLADIB ......................................................................................................................... 1669
Summary ....................................................................................................................................... 1669

Originators ..................................................................................................................................... 1670
Clinical Data: .................................................................................................................................. 1670
617) VARICELLA ZOSTER VACCINE ................................................................................................. 1672
Summary ....................................................................................................................................... 1672

Originators ..................................................................................................................................... 1672
Clinical Data: .................................................................................................................................. 1672
618) VARISOLVE ............................................................................................................................. 1674
Summary ....................................................................................................................................... 1675

Originators ..................................................................................................................................... 1675
Clinical Data: .................................................................................................................................. 1675
619) VATALANIB ............................................................................................................................ 1677
Summary ....................................................................................................................................... 1677

Originators ..................................................................................................................................... 1677
Clinical Data: .................................................................................................................................. 1678
620) VB4-845 (SQUAMOUS CELL CANCER).................................................................................... 1680
Summary ....................................................................................................................................... 1680

Originators ..................................................................................................................................... 1680
Clinical Data: .................................................................................................................................. 1680
621) VEDOLIZUMAB....................................................................................................................... 1682
Summary ....................................................................................................................................... 1682

Originators ..................................................................................................................................... 1683
Clinical Data: .................................................................................................................................. 1683
622) VEGF GENE THERAPY ............................................................................................................. 1685
Summary ....................................................................................................................................... 1685

Originators ..................................................................................................................................... 1685

Clinical Data: .................................................................................................................................. 1685
623) VEGF TRAP ............................................................................................................................. 1687
Summary ....................................................................................................................................... 1688

Originators ..................................................................................................................................... 1688
Clinical Data: .................................................................................................................................. 1688
624) VEGF TRAP-EYE ...................................................................................................................... 1690
Summary ....................................................................................................................................... 1690

Originators ..................................................................................................................................... 1690
Clinical Data: .................................................................................................................................. 1691
625) VICRIVIROC ............................................................................................................................ 1693
Summary ....................................................................................................................................... 1693

Originators ..................................................................................................................................... 1693
Clinical Data: .................................................................................................................................. 1693
626) VINFLUNINE ........................................................................................................................... 1695
Summary ....................................................................................................................................... 1695

Originators ..................................................................................................................................... 1696
Clinical Data: .................................................................................................................................. 1696
629) VINORELBINE ......................................................................................................................... 1698
Summary ....................................................................................................................................... 1698

Originators ..................................................................................................................................... 1698
Clinical Data: .................................................................................................................................. 1698
630) VIRAMIDINE ........................................................................................................................... 1700
Summary ....................................................................................................................................... 1701

Originators ..................................................................................................................................... 1701
Clinical Data: .................................................................................................................................. 1701
631) VIRULIZIN ............................................................................................................................... 1703

Summary ....................................................................................................................................... 1703
Originators ..................................................................................................................................... 1703
Clinical Data: .................................................................................................................................. 1704
632) VITAXIN .................................................................................................................................. 1706
Summary ....................................................................................................................................... 1706

Originators ..................................................................................................................................... 1706
Clinical Data: .................................................................................................................................. 1706
633) VITREOSOLVE......................................................................................................................... 1708
Summary ....................................................................................................................................... 1708

Originators ..................................................................................................................................... 1709
Clinical Data: .................................................................................................................................. 1709
634) VOCLOSPORIN ....................................................................................................................... 1711
Summary ....................................................................................................................................... 1711

Originators ..................................................................................................................................... 1711
Clinical Data: .................................................................................................................................. 1711
635) VRX-806 ................................................................................................................................. 1713
Summary ....................................................................................................................................... 1714

Originators ..................................................................................................................................... 1714
Clinical Data: .................................................................................................................................. 1714
636) WOUND HEALING AGENT...................................................................................................... 1716
Summary ....................................................................................................................................... 1716

Originators ..................................................................................................................................... 1716
Clinical Data: .................................................................................................................................. 1717
637) WX-G250................................................................................................................................ 1719
Summary ....................................................................................................................................... 1719

Originators ..................................................................................................................................... 1719

Clinical Data: .................................................................................................................................. 1719
638) XEMILOFIBAN ........................................................................................................................ 1721
Summary ....................................................................................................................................... 1721

Originators ..................................................................................................................................... 1722
Clinical Data: .................................................................................................................................. 1722
639) XERECEPT ............................................................................................................................... 1724
Summary ....................................................................................................................................... 1724

Originators ..................................................................................................................................... 1724
Clinical Data: .................................................................................................................................. 1724
640) XL-184 .................................................................................................................................... 1726
Summary ....................................................................................................................................... 1727

Originators ..................................................................................................................................... 1727
Clinical Data: .................................................................................................................................. 1727
641) XRP-9881 ............................................................................................................................... 1729
Summary ....................................................................................................................................... 1729

Originators ..................................................................................................................................... 1729
Clinical Data: .................................................................................................................................. 1729
642) YY-280 .................................................................................................................................... 1731
Summary ....................................................................................................................................... 1732

Originators ..................................................................................................................................... 1732
Clinical Data: .................................................................................................................................. 1732
643) ZANOLIMUMAB ..................................................................................................................... 1734
Summary ....................................................................................................................................... 1734

Originators ..................................................................................................................................... 1734
Clinical Data: .................................................................................................................................. 1735

644) ZERENEX ................................................................................................................................ 1737
Summary ....................................................................................................................................... 1737

Originators ..................................................................................................................................... 1737
Clinical Data: .................................................................................................................................. 1737
645) ZOLMITRIPTAN ORAL DISPERSIBLE FILM ............................................................................... 1739
Summary ....................................................................................................................................... 1739

Originators ..................................................................................................................................... 1739
Clinical Data: .................................................................................................................................. 1740
646) ZURAGEN ............................................................................................................................... 1742
Summary ....................................................................................................................................... 1742

Originators ..................................................................................................................................... 1742
Clinical Data: .................................................................................................................................. 1742
647) ZYC-101A ............................................................................................................................... 1744
Summary ....................................................................................................................................... 1744

Originators ..................................................................................................................................... 1744
Clinical Data: .................................................................................................................................. 1745
CBDM.T – Market and Business Intelligence – The Company........................................................... 1748

CBDM.T – Market and Business Intelligence – The Company
CBDMT® - THE MARKET AND BUSINESS INTELLIGENCE

COMPANY
CBDMT links innovation to markets by providing solutions to better characterize:

Market Uncertainty: How large is the potential market?
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the economic-technological war beats its drum, differentiation is a major asset. This is why, at
CBDM.T®, our job is to chart and analyze, in an objective and exhaustive way, all players and
technologies of the market in order to establish a powerful market-oriented strategy.
CBDM.T® is a market and business intelligence company with offices in France, Switzerland and
Israel. As an advisory services company, CBDM.T® boosts companies to develop revenue and growth
by providing business and marketing services in the life science and biotech markets (market surveys,
market scouting, business development and strategic supports).
CBDM.T® provides to small, medium and large companies technology-based business development
support to identify new customers and also to fine-tune a business strategy. Typically, CBDM.T®
interacts with its clients as business development or executive partners to maximize effectiveness
and minimize risks to sound out international markets (WOI - Window Opportunity Identification).

“Copyright 2010 CBDM.T SARL - Market and Business Intelligence. All rights reserved. Any unauthorized use or disclosure is
prohibited. The information herein was obtained from various sources; we do not guarantee its accuracy or completeness.
This research report is prepared for general circulation and is circulated for general information only. It does not have
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Author: Philippe Tramoy

Date: 20 September 2010

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