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

TITUSVILLE, N.J., April 29 /PRNewswire/ -- Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) today announced an agreement with the U.S. Attorney's Office for the District of Massachusetts, the U.S. Department of Justice, and other federal agencies to resolve a previously reported government investigation of past U.S. marketing and promotional practices for TOPAMAX® (topiramate), an antiepileptic and migraine prevention prescription medicine.  

Ortho-McNeil-Janssen Pharmaceuticals, Inc. has been cooperating with the government since its investigation began in December 2003.  OMJPI has entered into a settlement agreement resolving the federal government's investigation.  The settlement includes total payments of $81.5 million plus interest, an amount previously reserved for, to the federal government and state Medicaid programs.

As one part of the resolution, Ortho-McNeil Pharmaceutical, L.L.C., a subsidiary of OMJPI, has agreed to plead guilty to a single misdemeanor violation of the Food, Drug and Cosmetic Act and to pay a $6.1 million criminal fine.  OMJPI denies it engaged in any wrongful conduct, with the exception of acknowledging the admissions made by Ortho-McNeil Pharmaceutical, L.L.C.  in connection with the misdemeanor plea. The guilty plea is subject to approval by the U.S. District Court for the District of Massachusetts. The balance of the total settlement amount, $75.4 million, is a civil payment, part of which will be paid to the federal government and part of which will be made available to states for their Medicaid programs.

The plea states that the subsidiary, Or
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SOURCE Ortho-McNeil-Janssen Pharmaceuticals, Inc.
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