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Ortho-McNeil-Janssen Pharmaceuticals, Inc. Resolves Investigation of Past TOPAMAX(R) Marketing and Promotional Activities
Date:4/29/2010

tho-McNeil Pharmaceutical, L.L.C., through one of its promotional programs, in some instances between 2001 and 2003, promoted TOPAMAX for certain uses not approved by the U.S. Food and Drug Administration.  Ortho-McNeil Pharmaceutical, L.L.C. voluntarily discontinued the program at issue before receiving the government's first subpoena in the investigation.  

OMJPI has a robust compliance program, which it will continue as part of this settlement through a five-year corporate integrity agreement (CIA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS).  

The CIA is largely consistent with the Company's existing compliance program, and reflects OMJPI's commitment to ensuring integrity in the delivery of essential medicines to patients.   OMJPI's existing compliance program includes: a chief compliance officer; corporate compliance committee; code of conduct; extensive compliance training, policies and procedures regarding the appropriate promotion of OMJPI products; auditing, monitoring, and reporting, including a compliance hotline; and processes for disciplinary and corrective action.  

Ortho-McNeil-Janssen Pharmaceuticals, Inc. provides medicines for an array of health concerns. The company strives to provide innovative, high quality, safe and effective treatments and continually seeks new opportunities to offer solutions for unmet health care needs. Ortho-McNeil-Janssen Pharmaceuticals, Inc. is headquartered in Titusville, New Jersey. For more information, visit www.omjpi.com.

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SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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