WASHINGTON, April 24 (UPI) -- The U.S. Food and Drug Administration has approved the first generic versions of Ambien (zolpidem tartrate) for the treatment of insomnia.
The immediate-release tablets of Zolpidem tartrate provide a sedative-hypnotic drug indicated for the short-term treatment of the medical condition.
Zolpidem tartrate tablets in formulations of 5 milligrams and 10 milligrams are manufactured by several U.S. generic drug companies. Receiving FDA approval Monday were: Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals Inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.
According to the online magazine Drug Topics, Ambien was the 13th highest selling brand name drug during 2006. The Sanofi-Aventis Inc. patent for zolpidem tartrate expired last week.
