Lupin Ltd announced via an exchange filing that it has received approval from the USFDA for its generic version of Prasugrel tablets.
The medication is recommended for use in patients who have recently experienced heart attacks, strokes, or blood clots in stents in order to prevent other severe heart and blood vessel issues.
The company said in the regulatory filing that the US Food and Drug Administration (US FDA) had approved the Abbreviated New Drug Application (ANDA) for Prasugrel tablets in strengths of 5 mg and 10 mg.
These are the 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,” it added.
Prasugrel Tablets 5 mg and 10 mg had estimated annual sales of USD 18 million in the US, Lupin said citing IQVIA MAT September 2022 data.