Mylan Labs Gets FDA Approval for Generic Version of Ambien

Generic and proprietary drug manufacturer Mylan Laboratories announced yesterday that the FDA has granted final approval for the release of its generic version of Sanofi-Aventis's Ambien. The drug, zolpidem tartrate, is a nonbenzodiazepine hypnotic, otherwise known as a sleeping pill. The tablets, which are shipping immediately, are in 5 mg and 10 mg doses. Last year, Ambien had U.S. sales of approximately $2.2 billion for the same dosages. Mylan's drug is one of 13 generic versions of Ambien approved by the FDA for release. Other manufacturers now cleared to produce the drug include Teva Pharmaceuticals and Dr. Reddy's Laboratories. Zolpidem tartrate has been linked to several risks, like "sleep-driving" and face-swelling, that prompted the FDA to ask manufacturers of the drug to strengthen the language on its warning labels. Mylan Labs has three subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India.

Sources: Press release, MarketWatch, Reuters, MoneyCentral
Commentary: FDA Refuses Approval To Generics Of Pfizer Drug, Except Mylan • FDA Issues New Warning Label Requirement for Sleeping Pills • Biotech Legal Battles: Will Other Generics Follow Mylan's Lead?
Stocks/ETFs to watch: Mylan Laboratories Inc. (MYL), Sanofi-Aventis (SNY). Competitors: Dr. Reddy's Laboratories Limited [ADR] (RDY), Teva Pharmaceutical Industries Ltd. (TEVA), Barr Pharmaceuticals Inc. (BRL), Watson Pharmaceuticals Inc. (WPI). ETFs: SPDR S&P Pharmaceuticals (XPH)

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