Pradaxa Approval History
- FDA approved: Yes (First approved October 19th, 2010)
- Brand name: Pradaxa
- Generic name: dabigatran etexilate
- Dosage form: Capsules
- Company: Boehringer Ingelheim Pharmaceuticals, Inc.
- Treatment for: Prevention of Thromboembolism in Atrial Fibrillation, Deep Vein Thrombosis, Pulmonary Embolism
Pradaxa (dabigatran etexilate) is a direct thrombin inhibitor indicated to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation; and for the treatment and reduction of risk of deep vein thrombosis and pulmonary embolism.
Development History and FDA Approval Process for Pradaxa
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