13 Aug 2024 , 12:48 PM
Alembic Pharmaceuticals Limited today said it has got the final approval from the US Food and Drug Administration for Dabigatran Etexilate Capsules, 110 mg.
The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to Pradaxa Capsules, 110 mg of Boehringer Ingelheim Pharmaceuticals, Inc., the company said.
Dabigatran Etexilate Capsules 110 mg are indicated for prophylaxis of deep vein thrombosis and pulmonary embolism following hip replacement surgery.
Alembic has a cumulative total of 211 ANDA approvals, including 183 final approvals and 28 tentative approvals, from the US FDA.
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