Xarelto Approval History beta

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)

FDA Approval History for Xarelto

DateArticle
Jun 28, 2013Approval FDA 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.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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