FDA gives the go-ahead for generic Ambien

April 30, 2007

The sedative-hypnotic is indicated for the short-term treatment of insomnia. Zolpidem tablets in formulations of 5 and 10 mg are manufactured by multiple U.S. generic drug companies.

The FDA approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. The sedative-hypnotic is indicated for the short-term treatment of insomnia. Zolpidem tablets in formulations of 5 and 10 mg are manufactured by multiple U.S. generic drug companies. Thirteen manufacturers have received FDA approval for manufacturing zolpidem tablets. They are: Mylan, Teva, Roxane, Watson, Ranbaxy, Dr. Reddy's Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical, Caraco, Carlsbad Technology, and Lek Pharmaceuticals.

To see more Hot off the Press news articles, click here.

To go to the Drug Topics homepage, click here.