MYLAN WINS TENTATIVE APPROVAL FOR GENERIC DEPAKOTE ER

Mylan Laboratories announced that Mylan Pharmaceuticals received tentative approval from the FDA for its abbreviated new drug application for divalproex sodium extended-release (ER) tablets, 250 and 500 mg.

The product is the generic version of Abbot Laboratories' Depakote ER, which had total U.S. sales of approximately $698 million for the 250- and 500-mg strengths last year, Mylan said, citing IMS Health data.

Depakote ER is approved for treating mania associated with bipolar disorder and certain types of epilepsy and for preventing migraine headaches.