Mylan Announces Tentative FDA Approval for Divalproex Sodium Extended-Release Tablets
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- Published on Thursday, 15 March 2007 02:00
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PITTSBURGH, PA, USA | Mar 14, 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 Divalproex Sodium Extended-release (ER) Tablets, 250mg and 500mg strengths.
Divalproex Sodium ER Tablets are the generic version of Abbot Laboratories' Depakote ER(R) Tablets, which had U.S. sales of approximately $698 million 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 Inc.