Xarelto FDA Approval History
Last updated by Judith Stewart, BPharm on Dec 26, 2021.
FDA Approved: Yes (First approved July 1, 2011)
Brand name: Xarelto
Generic name: rivaroxaban
Dosage form: Tablets and Oral Suspension
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Deep Vein Thrombosis Prophylaxis after Knee Replacement Surgery, Deep Vein Thrombosis Prophylaxis after Hip Replacement Surgery, Prevention of Thromboembolism in Atrial Fibrillation, Coronary Artery Disease, Peripheral Arterial Disease, Deep Vein Thrombosis, Pulmonary Embolism, Venous Thromboembolism
Xarelto (rivaroxaban) is a factor Xa inhibitor used for the treatment and prevention of blood clots that are related to certain conditions involving the heart and blood vessels.
- Xarelto (rivaroxaban) is indicated:
- to reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation
- for treatment of deep vein thrombosis (DVT)
- for treatment of pulmonary embolism (PE)
- for reduction in the risk of recurrence of DVT or PE
- for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
- for prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients
- to reduce the risk of major cardiovascular events in patients with coronary artery disease (CAD)
- to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD
- for treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years
- for thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure.
- Xarelto is usually taken orally once or twice daily, dependent on the condition.
- Common adverse reactions in adult patients: bleeding.
Common adverse reactions in pediatric patients: bleeding, cough, vomiting, and gastroenteritis.
Development timeline for Xarelto
Further information
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