Bristol-Myers Squibb Company and Otsuka Pharmaceutical announced that the FDA approved the supplemental New Drug Application for Abilify (aripiprazole) as adjunctive, or add-on, treatment to antidepressant therapy in adults with major depressive disorder (MDD).

Roche announced that the FDA has approved Mircera (methoxy polyethylene glycol-epoetin beta) for the treatment of anemia associated with chronic renal failure (CRF) in adults, including patients on dialysis and patients not on dialysis.

AstraZeneca announced that the FDA has approved Crestor (rosuvastatin calcium) as an adjunct to diet to slow the progression of atherosclerosis in patients with elevated cholesterol.

The FDA said today it has approved Zyrtec-D (cetirizine HCl 5 mg and pseudoephedrine HCl 120 mg) as an OTC product for adults and children 12 years of age and older.

The FDA has granted marketing approval to Genzyme for its Renvela treatment for the control of serum phosphorus in patients with chronic kidney disease on dialysis.

The FDA has approved Ixempra (ixabepilone), a new anti-cancer treatment, for use in patients with metastatic or locally advanced breast cancer who have not responded to certain other cancer drugs.

Merck announced that the FDA has granted Isentress (raltegravir) tablets accelerated approval for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

Boehringer Ingelheim Pharmaceuticals announced that the FDA has granted full approval of Aptivus (tipranavir) capsules.

Sanofi-Aventis and Bristol-Myers Squibb said the FDA Administration has approved a supplemental new drug application for a 300 mg tablet of the antiplatelet drug Plavix (clopidogrel bisulfate).

GlaxoSmithKline announced that the European Commission has granted a marketing authorization for its cervical cancer vaccine, Cervarix, for all 27 European member states.