Mylan’s Generic Depakote Gets Tentative OK

Mylan said Wednesday the U.S. Food and Drug Administration granted tentative approval to its generic version of Abbott’s Depakote ER.

The tentative approval means Mylan may not launch its generic drug until the patent on Depakote ER expires. Mylan is seeking approval for 250 mg and 500 mg strengths of its tablets, known by the generic name divalproex sodium extended-release.

Abbott’s Depakote ER, which is indicated for the treatment of bipolar disorder, epilepsy and the prevention of migraines, had U.S. sales of $698 million for the same strengths in 2006.

Last month, Mylan received tentative approval from the FDA for its generic version of GlaxoSmithKline’s Zofran ODT, an orally disintegrating tablet indicated for the prevention of postoperative nausea and vomiting.