Alembic Pharma announces US FDA tentative approval for Dabigatran Etexilate capsules

Alembic Pharma today announced that it has received tentative approvals from the US Food and Drug Administration (FDA) 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 (RLD) product Pradaxa capsules, 75 mg, 110 mg, and 150 mg, of Boehringer Ingelheim Pharma, Alembic Pharma said in a statement.

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, the statement said.

Dabigatran Etexilate capsules, 75 mg, 110 mg, and 150 mg have an estimated market size of $465 million for twelve months ending December 2021 according to IQVIA, concluded the statement.