The U.S. Food and Drug Administration has issued final approval to Ranbaxy Laboratories Limited (RLL) and Dr. Reddy’s Laboratories Limited to market Nefazodone Hydrochloride tablets, 50 mg, 100 mg, 150 mg, 200 mg, and 250 mg.
Nefazodone hydrochloride is the AB-rated generic equivalent of Bristol Myers Squibb’s Serzone. Serzone is indicated for the treatment of depression. As per IMS 2002, the product had annual US brand sales of approximately $261 million.
Dr Reddys will market the product through the Company’s alliance partner, Par Pharmaceuticals.