Alembic Pharmaceuticals receives USFDA approval for Dabigatran Etexilate Capsules

13 Apr 2022 , 01:34 AM

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