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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

Oct 14, 2019Approval  FDA Approves Xarelto (rivaroxaban) to Help Prevent Blood Clots in Acutely Ill Medical Patients
Oct 11, 2018Approval  FDA Approves Xarelto to Reduce the Risk of Major Cardiovascular Events in Patients with Chronic Coronary Artery Disease (CAD) or Peripheral Artery Disease (PAD)
Oct 30, 2017Approval  FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)
Jun 28, 2013FDA Issues Complete Response Letter for Xarelto (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome
Nov  2, 2012Approval  FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots
Nov  4, 2011Approval  FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
Jul  1, 2011Approval  FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
Jan  5, 2011New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation
Jul 16, 2009New Drug Application for Rivaroxaban in the U.S.
May 28, 2009U.S. FDA Issues Complete Response Letter for Rivaroxaban
Mar 20, 2009FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery
Jul 30, 2008Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.

Further information

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