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U.S. FDA Grants Priority Review for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Date:2/27/2012

s called anticoagulants, and works by blocking the blood clotting Factor Xa, thereby reducing the tendency to form clots. In the U.S., XARELTO® is indicated to reduce the risk of forming a blood clot in the legs and lungs of people who have just had knee or hip replacement surgery and to reduce the risk of stroke and blood clots in people with atrial fibrillation, not caused by a heart valve problem. There is limited information on how XARELTO® compares to a medicine called warfarin in reducing the risk of stroke when the blood levels of warfarin are well-controlled. The blood levels of warfarin often vary in patients.

Additionally, XARELTO® is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. Rivaroxaban is being developed jointly by JRD and Bayer HealthCare. U.S. marketing rights for XARELTO® are held by Janssen Pharmaceuticals, Inc.

About Janssen Research & Development, LLC

At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc., are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

Important Safety Information

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO®?

For people taking XARELTO® for atrial fibrillation:

People with atrial fibrillation (an irregular h
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SOURCE Janssen Research & Development, LLC
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