SPOTLIGHT -
Humira
This recombinant IgG1 monoclonal antibody exerts its therapeutic effect through inhibition of human tumor necrosis factor (TNF).
Arranon
The prodrug of a cytotoxic deoxyguanosine analogue, nelarabine inhibits DNA synthesis and leads to cell death.
FDA actions in brief
FDA approved a new influenza vaccine (Fluarix, GlaxoSmith-Kline) for adults aged 18 years and older.
First-time generic approvals
Clonazepam orally disintegrating tablets 0.125, 0.25, 0.5, 1, and 2 mg (equiv to Klonopin rapidly disintegrating tablets).
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Nelarabine (Arranon, GlaxoSmithKline) injection for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma in pediatric and adult patients whose disease has not responded to or has relapsed following treatment with at least 2 chemotherapy regimens.
Ambien CR
This non-benzodiazepine hypnotic is delivered in 2 stages through the use of a bi-layered tablet.
Remicade
Infliximab, a chimeric monoclonal antibody, exerts its effect through inhibition of human tumor necrosis factor alpha (TNF alpha).
Pregabalin (Lyrica, Pfizer) was granted an expanded indication to include the adjunctive treatment of partial onset seizures in adults with epilepsy.
Aptivus
Accelerated approval granted for protease inhibitor
Byetta
First-in-class approved for type 2 diabetes
First-time generic approval
Mometasone topical solution 0.1% (equiv to Elocon topicallotion)
Tygacil
Broad spectrum antibiotic approved for cSSSIs and cIAIs
A new once-weekly formulation of alendronate in combination with 2,800 IU of vitamin D3 (Fosamax Plus D, Merck) was approved by FDA. The combination is indicated for the treatment of osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
Xibrom
Twice-daily ophthalmic NSAID approved to reduce inflammation after cataract surgery
Baraclude
Oral therapy approved for hepatitis B infection
Anti-sense compound (LR3001, Genta) for the treatment of chronic myelocytic leukemia
Hyzaar
Combination indicated to reduce risk of stroke in hypertensive patients with LVH
Peginterferon alfa-2a (Pegasys, Roche) and ribavirin (Copegus, Roche) were approved in combination for the treatment of chronic hepatitis C in patients coinfected with HIV who have clinically stable HIV disease.
Symlin
This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-?-D-glucan, an essential component of fungal cell walls.
Mycamine
This novel echinocandin antifungal exerts its antibiotic activity by inhibiting the synthesis of 1,3-β-D-glucan, an essential component of fungal cell walls.
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Surfactant replacement therapy (Surfaxin, Discovery Laboratories) for the prevention of respiratory distress syndrome (RDS) in premature infants
New indications: Aripiprazole
Atypical antipsychotic approved for acute bipolar mania This atypical antipsychotic is believed to exert its effect through a combination of partial agonist activity at D2 and 5-HT1A receptors and antagonist activity at 5-HT2A receptors. An expanded indication for aripiprazole was approved on September 29, 2004, to include the treatment of acute manic and mixed episodes associated with Bipolar Disorder.
Caduet (Amlodipine and atorvastatin) PFIZER
Calcium channel blocker/statin combination receives approval
Avastin (Bevacizumab) GENENTECH
First angiogenesis-inhibiting cancer therapy approved
Spiriva HandiHaler (Tiotropium)
Anticholinergic approved for COPD
Erbitux (Cetuximab)
Chimeric monoclonal antibody targets EGFR for the treatment of colon cancer
Symbyax (Olanzapine and fluoxetine capsules) LILLY
First combination approved specifically for bipolar depression
Lexapro (Escitalopram) FOREST
SSRI approved for generalized anxiety disorder
Vfend (Voriconazole) PFIZER
Triazole antifungal approved for treatment of esophageal candidiasis