Generic Ambien Approved

Monday, April 23, 2007; 12:00 AM
http://www.washingtonpost.com/wp-dyn...042301566.html

MONDAY, April 23 (HealthDay News) -- The first generic versions of the popular sleep aid zolpidem tartrate, brand name Ambien, have been approved by the U.S. Food and Drug Administration.

In a statement, the agency said 13 manufacturers had been given license to produce 5-milligram and 10-milligram versions of the drug, which it cited as the 13th best-selling medication in the United States. The drug is sanctioned as a short-term treatment for insomnia.

Generic versions of Ambien will include the same warning label as the brand-name drug, the agency said. Warnings will include the potential for severe allergic reactions and what the FDA called "complex sleep-related behaviors," including the possibility of "sleep driving" while not fully awake.

The brand name drug is produced by Sanofi-Aventis, whose patent expired earlier this month.

More information

The FDA has a list of the companies given approval to produce generic versions of Ambien.


FDA Approves First Generic Versions of Ambien (Zolpidem Tartrate) for the Treatment of Insomnia

FOR IMMEDIATE RELEASE
P07-72
April 23, 2007
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01616.html

The U.S. Food and Drug Administration (FDA) today approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedative-hypnotic drug indicated 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," said Gary J. Buehler, director, Office of Generic Drugs. "This approval offers Americans more alternatives when choosing their prescription drugs."

Zolpidem tartrate tablets in formulations of five milligrams and 10 milligrams are manufactured by multiple generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: 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.

In March, FDA requested that all manufacturers 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. For more information see www.fda.gov/bbs/topics/NEWS/2007/NEW01587.html. Generic versions of these drugs will also include this labeling.

According to the online magazine Drug Topics, in 2006, Ambien was the 13th highest selling brand name drug. The sanofi-aventis (formerly Sanofi-Synthelabo, Inc.) patent for zolpidem tartrate expired on April 21, 2007.

The FDA’s Office of Generic Drugs (OGD) reviews and decides on approval of generic drug applications. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/.

For more information about generic drugs, please see the FDA Consumer article, Generic Drugs: What You Need to Know at www.fda.gov/fdac/features/2002/502_generic.html. For additional information related to FDA's Office of Generic Drugs, please see: www.fda.gov/cder/consumerinfo/generic_equivalence.htm.