Pharmaceutical Business review

Mylan obtains FDA approval for generic Depakote ER

Mylan has been awarded 180 days of marketing exclusivity for the 500mg strength, which it will begin to ship February 2, 2009. Mylan was the first company to file a substantially complete abbreviated new drug application containing a Paragraph IV certification for the 500mg strength.

Divalproex Sodium extended-release (Divalproex ER) tablets are the generic version of Abbott Laboratories’s Depakote ER.