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Allergan Hit With $600 Million Settlement Over Botox

Posted Sep 08 2010 7:30am

Allergan Inc. reached a $600 million settlement with the U.S. government to resolve criminal and civil allegations that the company actively promoted its top-selling product, the wrinkle-smoothing drug Botox, for unapproved medical uses. The Irvine, Calif., company agreed to plead guilty to one misdemeanor charge pegged to misbranding the drug between 2000 and 2005. Allergan also settled civil claims linked to three whistleblower lawsuits, but denied liability with regard to the civil claims. The company will take a $610 million to $615 million pretax charge in the third quarter.

Source: http://online.wsj.com/article/SB10001424052748703882304575465371767239834.html

Allergan and many other drug companies promote their drugs for non FDA approved uses. Maybe Allergan was more aggressive about it. Off label use is pretty typical for botulinum toxins and most of these are pretty safe. The law doesn’t always make much sense.

Best Regards,

John Di Saia MD

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