Alembic Pharma receives USFDA Tentative Approval for Dabigatran Etexilate Capsules

Vadodara: Alembic Pharmaceuticals Limited announced that the company has received tentative approval from the US Food & Drug Administration (USFDA) 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 product (RLD) PRADAXA® Dabigatran Etexilate Mesylate Capsules, Eq to 150 mg base, Boehringer Ingelheim.

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 5 to 10 days.

It is also indicated to reduce the risk of recurrence of DVT and PE in patients who have been previously treated.

Dabigatran Etexilate Capsules, 150 mg have an estimated market size of US$ 726.3 million for twelve months ending December 2016 according to IMS.

Alembic now has a total of 60 ANDA approvals (52 final approvals and 8 tentative approvals) from USFDA.