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Cephalon pays $425 million.

Cephalon Inc. has agreed to pay more than $425 million to settle claims that it inappropriately marketed three drugs for off-label uses, according to the U.S. Justice Department. The settlement will resolve civil and criminal complaints alleging that the company marketed Gabitril (tiagabine), Actiq (oral transmucosal fentanyl), and Provigil (modafinil) for off-label uses. Between 2001 and 2006, Cephalon allegedly promoted Actiq, which is an approved pain treatment in opioid-tolerant cancer patients, as a treatment for migraine, sickle-cell pain, and injuries. Gabitril was allegedly promoted for treatment of anxiety, insomnia, and pain. Provigil, which was originally approved to treat excessive daytime sleepiness associated with narcolepsy, was allegedly promoted off-label as a nonstimulant drug for sleepiness, tiredness, decreased activity, and fatigue. Under the settlement, Cephalon has entered into a 5-year agreement with the Heath and Human Services Office of Inspector General that requires the company to notify physicians of the settlement terms and to begin disclosing any payments made to physicians on its Web site by Jan. 31, 2010.

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Title Annotation:POLICY & PRACTICE; inappropriate drug marketing for off-label use
Author:Anderson, Jane
Publication:Family Practice News
Article Type:Brief article
Date:Nov 1, 2008
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