Sun gets USFDA nod for version of Abbott drug

Sun Pharmaceuticals has obtained tentative approval from the USFDA for its abbreviated new drug application (ANDA) for Divalproex Sodium delayed release tablets, the generic version of Abbott's Depakote.

Divalproex Sodium delayed release tablets are indicated in the treatment of patients with various types of seizures including migraine.

The USFDA approvals are for the generic versions of Divalproex Sodium delayed release 125 mg, 250 mg and 500 mg (valproic and activity) tablets.

Other generic manufacturers eyeing the Depakote market, which had sales of approximately $755 million in the US, include Wockhardt, Israeli drug giant Teva, US-based Mylan, Impax, Nu Pharma and Canadian drug maker Apotex.