Unichem Lab receives ANDA nod for divalproex sodium extended-release tablets from USFDA

28 Feb 2022 , 11:16 AM

Unichem Laboratories has received ANDA approval for its Divalproex Sodium Extended-Release Tablets USP, 250 mg and 500 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Depakote ER (Divalproex Sodium) Extended-Release Tablets 250 mg and 500 mg, of AbbVie Inc.

Divalproex Sodium Extended-Release Tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches.

The product will be commercialized from Unichem’s Goa plant.

At around 11.13 am, Unichem was trading at Rs254.95 per piece down by 1.4%on BSE.

The stock has touched an intraday high and low of Rs260 per piece and Rs250.05 per piece.