Alembic Pharma gets USFDA's tentative approval for Dabigatran Etexilate Capsules

10 Jul 2017 Evaluate

Alembic Pharmaceuticals has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dabigatran Etexilate Capsules, 150 mg. Dabigatran Etexilate Capsules, 150 mg have an estimated market size of $726.3 million for twelve months ending December 2016. The company now has a total of 60 ANDA approvals (52 final approvals and 8 tentative approvals) from USFDA.

The tentatively approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) PRADAXAO 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.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907. The company manufactures and markets generic pharmaceuticals products all over the world.

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