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Janssen Research & Development Submits Application to U.S. FDA for XARELTO® (rivaroxaban) to Reduce Secondary Cardiovascular Events in Patients with Acute Coronary Syndrome
Date:12/29/2011

mbolism in patients with nonvalvular atrial fibrillation. There are limited data on the relative effectiveness of XARELTO® and warfarin in reducing the risk of stroke and systemic embolism in nonvalvular atrial fibrillation patients when warfarin therapy is well-controlled.

Additionally, XARELTO® is being evaluated for the prevention and treatment of a broad range of disorders in which blood clotting plays a major role. By the time of its completion, more than 75,000 patients will have participated in the rivaroxaban clinical development program. Rivaroxaban is being developed jointly by JRD and Bayer HealthCare. U.S. marketing rights for XARELTO® are held by Janssen Pharmaceuticals, Inc.

More information for patients and caregivers can be accessed at http://www.xarelto-us.com/.

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 Janssen Pharmaceutical Companies. Please visit http://www.janssenrnd.com for more information.

IMPORTANT SAFETY INFORMATION

 

WARNINGS: (A) DISCONTINUING XARELTO® IN PATIENTS WITH

NONVALVULAR ATRIAL FIBRILLATION INCREASES RISK OF STROKE,

(B) SPINAL/EPIDURAL HEMATOMA

 

A. DISCONTINUING XARELTO® IN PATIENTS WITH NONVALVULAR ATRIAL FIBRILLATION

Discontinuing XARELTO®
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SOURCE Janssen Research & Development, LLC
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