Watson Pharmaceuticals Inc has received final approval from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for nefazodone hydrochloride tablets in the 100 mg, 150 mg, 200 mg and 250 mg strengths.
Nefazodone hydrochloride is the generic equivalent of Bristol-Myers Squibb's Serzone and is indicated for the treatment of depression.
For the 12-months ending June 2003, Serzone had sales of approximately $220 million for all strengths, according to IMS data.
Watson's nefazodone hydrochloride product will be launched immediately, making it the Company's 21st product launched in 2003.