East Windsor, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application Dabigatran Etexilate Capsules, 75 mg, 110 mg, and 150 mg. Aurobindo Pharma’s Dabigatran Etexilate Capsules, are an AB-rated generic equivalent to the reference listed drug (RLD), Pradaxa Capsules manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

Dabigatran Etexilate Capsules are indicated:

• To reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation.
• For the treatment of deep venous thrombosis and pulmonary embolism in patients who have been treated with a parenteral anticoagulant for 5-10 days.
• To reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in patients who have been previously treated.