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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

Dec 20, 2021Approval FDA Approves Two New Indications for Xarelto (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
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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