FDA approved Alkermes and Cephalon’s Vivitrol (naltrexone for extended-release injectable suspension) for the treatment of alcohol dependence.
The FDA has granted final approval to Dr. Reddy’s Laboratories’ Abbreviated New Drug Application for fexofenadine hydrochloride tablets, 30 mg, 60 mg and 180 mg. Fexofenadine hydrochloride is the generic equivalent of Sanofi-Aventis’ allergy drug Allegra. Dr. Reddy’s said it will begin the commercial marketing of this product immediately.
Roche has filed for US approval of an expanded lung cancer indication for its Avastin colorectal cancer drug. Roche said studies show that Avastin is beneficial to patients with nonsquamous non-small-cell lung cancer, which accounts for 87% of all lung cancer cases in the US.