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). Abilify is the first medication approved by the FDA as add-on treatment for MDD.
Bradley Pharmaceuticals announced that its Doak Dermatologics subsidiary has launched Rosula CLK, a kit combining two topical skincare products currently marketed by Doak. The kit contains Rosula Clarifying Wash (Sodium Sulfacetamide 10% and Sulfur 4%) in a urea vehicle, and A-Fil Cream (meradimate 5% and titanium dioxide 5%) sunscreen.
Wyeth announced that the European Commission has approved Torisel (temsirolimus) for the first-line treatment of patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors. Torisel is the only approved cancer therapy that specifically inhibits the mTOR (mammalian target of rapamycin) kinase, an important regulator of cell proliferation, cell growth and cell survival. Torisel was approved in the US in May 2007 for the treatment of advanced RCC.
Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals announced that the FDA has approved a supplemental New Drug Application for Nexavar (sorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma or liver cancer. Nexavar, an oral anticancer drug, is the first approved systemic therapy for liver cancer and the only one shown to significantly improve overall survival in patients with the disease. In 2005, Nexavar became the first new treatment in more than a decade for advanced kidney cancer, and is currently approved in more than 60 countries for this indication.