Alembic Pharmaceuticals receives USFDA approval for Dabigatran Etexilate Capsules

7 Apr 2022 , 01:53 PM

Alembic Pharmaceuticals today announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Pradaxa? Capsules, 75 mg, 110 mg, and 150 mg, of Boehringer lngelheim Pharmaceuticals, Inc. (Boehringer).

Dabigatran Etexilate Capsules, are indicated for reduction of risk of stroke and systemic embolism in non-valvular atrial fibrillation in adult patients, treatment of deep venous thrombosis and pulmonary embolism in adult patients, reduction in the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients, prophylaxis of deep vein thrombosis and pulmonary embolism in adult patients following hip replacement surgery. It may not be indicated for certain other uses due to unexpired exclusivities for the RLD for such uses.

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