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.
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