Unichem Laboratories Limited announced that it has received ANDA approval for its Prasugrel Tablets USP, 5 mg and 10 mg from the United States Food and Drug Administration (USFDA) to market a generic version of Effient®? (Prasugrel) Tablets, 5 mg and 10 mg, of Cosette Pharmaceuticals Inc. Prasugrel tablets are indicated to reduce the rate of thrombotic CV events (including stent thrombosis) in patients with acute coronary syndrome. The product will be commercialized from Unichem's Goa Plant.
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- Unichem Laboratories Limited Receives ANDA Approval for its Prasugrel Tablets USP, 5 Mg and 10 Mg from the United States Food and Drug Administration