Xarelto Approval History

• FDA approved: Yes (First approved July 1st, 2011)
• Brand name: Xarelto
• Generic name: rivaroxaban
• 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)

FDA Approval History for Xarelto

Date	Article
Nov  2, 2012	FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots
Nov  4, 2011	FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm
Jul  1, 2011	FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery
Jan  5, 2011	New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation
Jul 16, 2009	New Drug Application for Rivaroxaban in the U.S.
May 28, 2009	U.S. FDA Issues Complete Response Letter for Rivaroxaban
Mar 20, 2009	FDA 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, 2008	Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S.

See also...

Xarelto (rivaroxaban) Consumer Information

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.