U.S. approves 13 generic versions of Ambien

Last Updated: 2007-04-24 13:24:15 -0400 (Reuters Health)

WASHINGTON (Reuters) - U.S. health officials have approved 13 cheaper generic alternatives to Ambien, a blockbuster sleeping pill from France's Sanofi-Aventis, the Food and Drug Administration said on Monday.

The controversial drug, known generically as zolpidem tartrate, has been linked to potentially dangerous risk behaviors, such as driving while asleep and allergic reactions. Like Ambien and other popular sleep drugs, the new generics will also have to carry warnings on their product labels, the FDA said.

Manufacturers cleared to make generic versions include Mylan Laboratories Inc., Teva Pharmaceutical Industries Ltd., Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Apotex Inc. and Synthon Pharmaceuticals Inc.

Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc. and Lek Pharmaceuticals also won FDA approval.

The generic makers will sell the drug, approved to treat short-term bouts of insomnia, in 5-milligram and 10-milligram doses.

Sanofi spokeswoman Emmy Tsui said the drugmaker will continue to sell Ambien as well as its extended release version, Ambien CR, which is also approved to help people stay asleep.

Both versions of Ambien brought in about 1.84 billion euros, or about $2.5 billion, in U.S. net sales in 2006, Tsui said. She declined to comment on how generic versions might impact sales.