What is the generic name?

DABIGATRAN ETEXILATE

What is the Trade Name for DABIGATRAN ETEXILATE?

Dabigatran Etexilate

What are the Indications for DABIGATRAN ETEXILATE?

• 1 INDICATIONS AND USAGE Dabigatran etexilate capsules are a direct thrombin inhibitors indicated: ‚Ä¢ To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation ( 1.1 ) ‚Ä¢ For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days ( 1.2 ) ‚Ä¢ To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated ( 1.3 ) 1.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. 1.2 Treatment of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated for the treatment of deep venous thrombosis and pulmonary embolism in adult patients who have been treated with a parenteral anticoagulant for 5 to 10 days. 1.3 Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Dabigatran etexilate capsules are indicated to reduce the risk of recurrence of deep venous thrombosis and pulmonary embolism in adult patients who have been previously treated. Pediatric use information is approved for Boehringer Ingelheim Pharmaceuticals, Inc.‚Äôs Pradaxa (dabigatran etexilate) capsules. However, due to Boehringer Ingelheim Pharmaceuticals, Inc.‚Äôs marketing exclusivity rights, this drug product is not labeled with that information.

References: https://open.fda.gov/