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:

• to reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation
• for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days
• to reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated
• for the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery
• for the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• to reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have been previously treated.

Pradaxa oral pellets are indicated:

• for the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days
• to reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated.

Development timeline for Pradaxa

Date	Article
Jun 21, 2021	Approval FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children
Nov 23, 2015	Approval FDA Approves Pradaxa for Prophylaxis of Deep Venous Thrombosis and Pulmonary Embolism after Hip Replacement Surgery
Apr  7, 2014	Approval FDA Approves Pradaxa for Deep Venous Thrombosis and Pulmonary Embolism
Oct 19, 2010	Approval FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
Sep 21, 2010	FDA Advisory Committee Unanimously Recommends Approval of Dabigatran Etexilate for Stroke Prevention in Atrial Fibrillation

Further information

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