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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

Nov 23, 2015Approval FDA Approves Pradaxa for Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism after Hip Replacement Surgery
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

Further information

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