Pradaxa FDA Approval History
FDA Approved: Yes (First approved October 19, 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 Timeline for Pradaxa
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