Pradaxa Approval History

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.

FDA Approval History for Pradaxa

DateArticle
Apr  7, 2014Approval FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism
Oct 19, 2010Approval FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
Sep 21, 2010FDA Advisory Committee Unanimously Recommends Approval of Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation

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