USFDA nod to Unichem Labs Prasugrel Tablets to reduce thrombotic CV events rate in acute coronary syndrome
Mumbai: Unichem Laboratories Limited has announced that the company has received abbreviated new drug application (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...
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Mumbai: Unichem Laboratories Limited has announced that the company has received abbreviated new drug application (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.
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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