Cephalon agrees to pay $425M to resolve off-label marketing allegations

5 October 2008

The US Justice Department has announced that biopharmaceuticals firm Cephalon will enter a criminal plea and pay $425.0 million to resolve claims that it marketed three drugs for uses that have not been not approved by the Food and Drug Administration.

The company said it has also reached separate agreements with the Attorneys General of the states of Connecticut and Massachusetts to settle related investigations into the company's sales and promotional practices. The initial investigations began in 2004 and involved three of the firm's nine proprietary products in the USA - Actiq (oral transmucosal fentanyl citrate), Provigil (modafinil) tablets and GabitRil (tiagabine HCl).

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