Unichem Labs gets USFDA nod for Divalproex Sodium ER Tablets
Mumbai: Drugmaker, Unichem Laboratories Limited, today announced that the company has received approval from the United States Food and Drug Administration (USFDA) for Divalproex Sodium Extended-Release Tablets USP, 250 mg and 500 mg.
The product is a generic version of Depakote ER (Divalproex Sodium) Extended-Release Tablets 250 mg and 500 mg, of AbbVie Inc.
"Unichem Laboratories Limited is pleased to announce that it 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," the company said in a BSE filing.
Divalproex Sodium Extended-Release Tablets are indicated for 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.
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Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.
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