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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