USFDA approves Prasugrel tablets by Lupin

The United States Food and Drug Administration (USFDA) has received approval from the United States Food and Drug Administration (USFDA) 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 Pharma. The product will be manufactured at Lupin’s facility in Goa, a statement from Lupin informed today.

Prasugrel tablets USP, 5 mg and 10 mg, had estimated annual sales of $18 million in the US (IQVIA MAT September 2022), the statement further said.