FDA Drug Approvals

and visual and auditory hallucinations have been reported in patients

treated with sedative-hypnotic
agents such as zolpidem. Complex
behaviors such as "sleep driving"
have also been reported in patients
treated with these agents.The concurrent use of alcohol or other central
nervous system (CNS) depressants
appears to increase the risk of these
behaviors occurring. Amnesia, anxiety, and other neuropsychiatric
symptoms have been reported to
occur unpredictably in patients
treated with sedative-hypnotic

agents. In patients with primary

depression, worsening of depression and suicidal thinking have
been reported in association with
sedative-hypnotic treatment. Cases
of angioederria involving the tongue,
glottis, or larynx have been reported
rarely in patients taking sedativehypnotic agents. The most common
adverse events reported in patients
treated with zolpidem include
drowsiness, headache, dizziness, diarrhea, allergy, sinusitis, lethargy,
drugged feeling, pharyngitis, dry
mouth, and back pain.

Zoledronic acid (Reclast, Novartis) was approved for the treatment of patients with Paget's disease ofthe bone.

Paliperidone (invega, Janssen) was approved for the long-term

maintenance treatment of schizophrenia. The agent was previously approved for the short-term treatment of schizophrenia.

Antihemophilic factor/von Willebrand factor complex (Humate-P,

CSL Behring) was approved for the prevention of excessive bleeding
in patients with von Willebrand disease who are undergoing
surgery. This agent was previously approved to treat and prevent bleeding in patients with hemophilia A and to treat spontaneous and traumatic bleeding in patients with severe von
Willebrand disease and in patients with mild-to-moderate von
Willebrand disease when desmopressin use is known or suspected to be inadequate.
Dalteparin injection (Fragmin, Eisai/Pfizer) was approved for
the extended treatment of symptomatic venous thromboembolism (VTE) (proximal deep vein thrombosis and/or pulmonary
embolism) to reduce the recurrence of VTE in patients with
cancer. This agent was previously approved for the
prevention of deep vein thrombosis in patients undergoing hip replacement surgery, in at-risk patients undergoing abdominal surgery, and in at-risk acutely ill patients whose mobility is severely restricted. The agent
is also approved for prophylaxis of ischemic complications resulting from unstable angina and non-Q-wave
in
myocardial infarction, when used with aspirin.

Fluticasone nasal spray (Veramyst, GlaxoSmithKline) was approved for the treatment of seasonal and year-round allergy
symptoms in adults and children aged >:2 years.
A once-yearly subcutaneous implant containing histrelin (Supprelin-LA, Indevus) was approved for the treatment of central
precocious puberty.
The labeling for abatacept (Orencia, Bristol-Myers Squibb)
was updated to change the agent's approved indication.
Previously, this agent was approved for slowing the progression of structural joint damage in adult patients with moderately to severely active rheumatoid arthritis who have had an
inadequate response to a l disease-modifying, antirheumatic drugs. The agent is now approved for inhibiting the progression of structural joint damage in
these patients.

actions
brief

Synthetic conjugated estrogens, B (Enjuvia, Duramed) was approved for the treatment of moderate-to-severe vaginal dryness and pain with intercourse, symptoms of vulvar and vaginal
atrophy, associated with menopause. This agent was previously approved for the treatment of moderate-to-severe vasomotor
symptoms associated with menopause. FDA also approved a
new 0.9-mg tablet strength of this agent.
Gemifloxacin (Factlve, Oscient) was approved for the 5-day treatment of community-acquired pneumonia of mild-to-moderate
severity. This agent was previously approved for the 7-day treatment of community-acquired pneumonia and for the 5-day treatment of acute bacterial exacerbations of chronic bronchitis.

362

Formulary

Dosing. The recommended zolpidem

dose for adults is 10 mg, taken immediately before beddme.The daily dose of
zolpidem should not exceed 10 mg.
Dose adjustments may be necessary in
patients also taking an agent with
known CNS-depressant effects and in
elderly or debilitated patients. Patients
with hepatic insufficiency should initially be treated with zolpidem 5 mg.
The zolpidem tablet may be taken with
or without water but should not be administered with or immediately after a
meal. Patients should not chew, break,
or split the tablet. F

June 2007 | Vol. 42 | www.formularyjournal.com

A prefilled disposable insulin pen (Lantus SoloStar,

Sanofi-Aventis) was approved for the once-daily treatment of hyperglycemia in patients with type 1 or type
2 diabetes.

A new dosage strength of alendronate/cholecalciferol (Fosamax, Merck) was approved for the treatment of osteoporosis in postmenopausal women. The new strength contains alendronate 70 mg and cholecalciferol (vitamin Dj) 5,600 IU.
A new lOfng tablet fonnulation of morphine extended-release (Kadian, Alpharma) was approved for the management of moderateto-severe chronic pain.
FDA has granted full approval for cytarabine liposome injection (DepoCyt, Enzon) for the treatment of patients with lymphomatous meningitis. This agent was previously granted accelerated approval.