Lupin gets US FDA nod for generic medicine to treat heart ailments

Pharmaceuticals firm Lupin Ltd on Tuesday said it has received approval from the US health regulator for its generic version of Prasugrel tablets.

The medicine is indicated to prevent other serious heart and blood vessel problems in patients with recent heart attacks, strokes and blood clots in stents.

The approval by the US Food and Drug Administration (US FDA) for the Abbreviated New Drug Application (ANDA) of Prasugrel tablets of strengths 5 mg and 10 mg, the company said in a regulatory filing.

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.