FDA News

Mylan Announces Tentative FDA Approval for Divalproex Sodium Extended-Release Tablets

(March 15, 2007)-- Mylan Pharmaceuticals 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.

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