FDA Actions in Brief

FDA granted tentative approval to a combination of valsartan and amlodipine (Exforge, Novartis) for the treatment of hypertension (approval pending the expiration of market exclusivity and patent protection for amlodipine).

A combination of clindamycin 1.2% and tretinoin 0.025% (Ziana Gel, Medicis and Dow Pharmaceutical Sciences) was approved for the topical treatment of acne vulgaris.

FDA approved ciclesonide (Omnaris, Altana Pharma US) for the treatment of nasal symptoms associated with seasonal and perennial allergic rhinitis.

An influenza vaccine available in 10-dose multidose vials (FluLaval, GlaxoSmithKline) was approved for the active immunization of adults against the flu.

Interferon beta-1b (Betaseron, Schering AG) was approved for the treatment of the early stages of multiple sclerosis.

FDA approved somatropin (rDNA origin) for injection (Huma-trope, Lilly) for the treatment of short stature or growth failure in children with SHOX deficiency.

Coagulation factor VIIa (recombinant) (NovoSeven, Novo Nordisk) was approved for the treatment of acquired hemophilia.

Donepezil (Aricept, Eisai) was approved for the treatment of severe dementia in patients with Alzheimer's disease.

Esomeprazole (Nexium, AstraZeneca) was approved for the treatment of Zollinger-Ellison syndrome; a delayed-release formulation (Nexium for Delayed-Release Oral Suspension) was approved for the treatment of GERD.

A new formulation of travoprost ophthalmic solution 0.004% (Travatan Z, Alcon) was approved for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of or insufficiently responsive to other intraocular pressure-lowering medications.

Fexofenadine (Allegra, Sanofi-Aventis) was approved as an oral suspension for the treatment of seasonal allergic rhinitis in children aged 2 to 11 years and for the treatment of chronic idiopathic urticaria in children aged 6 months to 11 years.

FDA approved atazanavir 300-mg single capsules (Reyataz, Bristol-Myers Squibb) as part of a combination regimen for the treatment of HIV-1 infection.

A controlled-release formulation of carvedilol (Coreg CR, Glaxo-SmithKline) was approved for the treatment of hypertension, post-myocardial infarction left ventricular dysfunction, and mild-to-severe heart failure.