Alembic gets USFDA nod for generic medication

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market a generic product indicated for prophylaxis of deep vein thrombosis. The company has received approval from the US Food and Drug Administration (USFDA) to market Dabigatran Etexilate Capsules (110 mg), the drug firm said in a regulatory filing.

Dabigatran Etexilate Capsules are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery. The approved product is therapeutically equivalent to Boehringer Ingelheim Pharmaceuticals Inc.'s Pradaxa Capsules (110 mg).

The company said it now has a cumulative total of 211 ANDA (abbreviated new drug application) approvals from the USFDA. Shares of the company on Tuesday closed 3.17 percent down at Rs 1,076 apiece on the BSE.