FDA Approves 13 Companies to Make Generic Version of Insomnia Drug
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Reviewed By Louise Chang, MD
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April 23, 2007 -- The FDA today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets.
Zolpidem tartrate is a sedative-hypnotic drug used for the short-term treatment of insomnia.
"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," the FDA's Gary J. Buehler, RPh, says in an FDA news release.
"This approval offers Americans more alternatives when choosing their prescription drugs," says Buehler, who directs the FDA's Office of Generic Drugs.
Zolpidem tartrate tablets in formulations of 5 milligrams and 10 milligrams are made by multiple generic drug companies in the U.S.
The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals, TEVA Pharmaceuticals USA, Roxane Laboratories, Watson Laboratories, Ranbaxy Laboratories, Dr. Reddy's Laboratories, Apotex, Synthon Pharmaceuticals, Genpharm, Mutual Pharmaceutical Company, Caraco Pharmaceutical Laboratories, Carlsbad Technology, and Lek Pharmaceuticals.
In March, the FDA requested that all makers of sedative-hypnotic drug products, a class of drugs used to induce and/or maintain sleep, strengthen their product labeling to include stronger language concerning potential risks.
These risks include severe allergic reactions and complex sleep-related behaviors, which may include sleep-driving. Sleep driving is defined as driving while not fully awake after ingestion of a sedative-hypnotic product, with no memory of the event.
Generic versions of these drugs will also include this labeling.
Ambien is made by Sanofi Aventis. The company's patent for zolpidem tartrate expired on April 21, 2007, according to the FDA. Sanofi Aventis' extended-release Ambien CR isn't available in generic versions.
SOURCE: News release, FDA.
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