Healthcare Industry News:  zolpidem 

Biopharmaceuticals Generics FDA

 News Release - April 23, 2007

Mylan Announces Final FDA Approval and Immediate Shipment of Zolpidem Tartrate Tablets

PITTSBURGH, April 23 (HSMN NewsFeed) -- Mylan Laboratories Inc. (NYSE: MYL ) today announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for zolpidem Tartrate Tablets, 5 mg and 10 mg. This product is being shipped immediately.

zolpidem Tartrate Tablets are the generic version of Sanofi-Aventis' AmbienĀ® Tablets. Ambien Tablets had U.S. sales of approximately $2.2 billion for the same strengths for the 12-month period ending Dec. 31, 2006, according to IMS Health.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.

For more information about Mylan, please visit www.mylan.com.


Source: Mylan Laboratories

Issuer of this News Release is solely responsible for its content.
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