Allergan Inc., the maker of wrinkle-smoothing Botox, says it will pay $600 million to settle a five-year-long federal investigation into its marketing of the top-selling, botulin-based drug.
The company said Wednesday in a statement it will plead guilty to one misdemeanor charge of "misbranding," in which the company's marketing led physicians to use Botox for unapproved uses. Those included the treatment of headache, pain, spasticity and cerebral palsy in children.
Companies are prohibited from promoting drugs for unapproved, or "off-label," uses.
Allergan, based in Irvine, Calif., said it will pay $375 million in connection with the plea. Additionally, the company will pay $225 million in civil fines related to the investigation, although the company denies liability for the civil claims.
Allergan's product sales topped $4.4 billion in 2009, with Botox accounting for more than $1.3 billion of that total.
The Justice Department's investigation covered Allergan's marketing of Botox from 2000 to 2005, and the settlement fees suggest Allergan made between $20 million and $50 million a year on off-label sales of the drug in that time, Wells Fargo analyst Larry Biegelsen said.
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