Lupin receives USFDA approval for Prasugrel Tablets

Lupin today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA), Prasugrel Tablets USP, 5 mg and 10 mg, a generic equivalent of Effient Tablets, 5 mg and 10 mg of Cosette Pharmaceuticals, Inc. The product will be manufactured at Lupin's facility in Goa, India.

Prasugrel Tablets USP, 5 mg and 10 mg, (RLD Effient) had estimated annual sales of USD 18 million in the U.S. (IQVIA MAT September 2022).

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