Alembic Pharmaceuticals announces US FDA tentative approval for Dabigatran Etexilate capsules

Alembic Pharmaceuticals yesterday announced that it has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. The tentatively approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Pradaxa Dabigatran Etexilate Mesylate capsules, Eq to 150 mg base, Boehringer Ingelheim, the company said in a statement.

It also said that Dabigatran Etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, and for the treatment of Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days. It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.