Pradaxa FDA Approval History
Last updated by Judith Stewart, BPharm on June 28, 2021.
FDA Approved: Yes (First approved October 19, 2010)
Brand name: Pradaxa
Generic name: dabigatran etexilate
Dosage form: Capsules and Oral Pellets
Company: Boehringer Ingelheim Pharmaceuticals, Inc.
Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Venous Thromboembolism
Pradaxa capsules are indicated:
- to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
- for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days
- to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated
- for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery
- for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days
- to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.
- for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days
- to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.
Development timeline for Pradaxa
Further information
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