Mylan Laboratories (MYL) Receives Tentative FDA Approval for Generic Depakote ER
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Mylan Laboratories Inc. (NYSE: MYL) 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' (NYSE: ABT) Depakote ER® 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.
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