Xarelto FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 7, 2020.
FDA Approved: Yes (First approved July 1, 2011)
Brand name: Xarelto
Generic name: rivaroxaban
Dosage form: Tablets
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
Xarelto (rivaroxaban) is a factor Xa inhibitor indicated:
- to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation
- for the treatment of deep vein thrombosis (DVT)
- for the treatment of pulmonary embolism (PE)
- for the reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months
- for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery
- for the prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients at risk for thromboembolic complications not at high risk of bleeding
- in combination with aspirin, to reduce the risk of major cardiovascular events (cardiovascular (CV) death, myocardial infarction (MI) and stroke) in patients with chronic coronary artery disease (CAD) or peripheral artery disease (PAD).
Development Timeline for Xarelto
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