Mylan Announces Tentative FDA Approval for Letrozole Tablets, USP
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- Published on Friday, 04 May 2007 04:00
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PITTSBURGH, PA, USA | May 3, 2007 | Mylan Laboratories Inc. (NYSE: MYL) today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Letrozole Tablets USP, 2.5 mg.
Letrozole Tablets are the generic version of Novartis Pharmaceuticals Corp.'s Femara(R) Tablets, which had U.S. sales of approximately $326 million for the same strength 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.
SOURCE: Mylan Laboratories