TUESDAY, April 24 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first generic versions of Ambien for the short-term treatment of insomnia. The patent for zolpidem tartrate, awarded to Sanofi-Aventis, expired in April this year.
The FDA has approved 13 manufacturers to produce the sedative-hypnotic in 5-mg and 10-mg formulations. The generic versions must carry clear warnings of the potential risks of the drug, which include severe allergic reactions and sleep-driving. The new labeling requirement was applied to Ambien starting in March.
"The FDA's Office of Generic Drugs ensures that generic drugs are safe and effective for the American public through a rigorous scientific and regulatory process. This approval offers Americans more alternatives when choosing their prescription drugs," Gary J. Buehler, R.Ph., director of the Office of Generic Drugs, said in a statement.
The manufacturers that have received FDA approval for zolpidem tartrate tablets are 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.
More Information
