Mylan Announces Final FDA Approval and Immediate Shipment of Zolpidem Tartrate Tablets
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- Published on Tuesday, 24 April 2007 04:00
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PITTSBURGH, PA, USA | April 23, 2007 | 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' Ambien(R) 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 http://www.mylan.com/.
SOURCE: Mylan Laboratories Inc.