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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 (dabigatran etexilate) is a direct thrombin inhibitor.
Pradaxa capsules are indicated: Pradaxa oral pellets are indicated:

Development timeline for Pradaxa

DateArticle
Jun 21, 2021Approval FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children
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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