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Xarelto Approval History

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

Xarelto (rivaroxaban) is a factor Xa inhibitor indicated for the prophylaxis of deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery, to reduce the risk of stroke in people who have abnormal heart rhythm (non-valvular atrial fibrillation) and to treat and reduce the risk of deep vein thrombosis (DVT) or pulmonary embolism (PE)

Development History and FDA Approval Process for Xarelto

DateArticle
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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