The maker of the popular anti-wrinkle treatment Botox Wednesday said it agreed to pay $600 million to settle a US probe into illegal marketing for so-called off-label uses.
It agreed to plead guilty to a single misdemeanor "misbranding" charge covering the period 2000 through 2005 and pay the government $375 million, the company said in a statement. It will pay an additional $225 million to resolve civil claims from the Justice Department under the False Claims Act, which relates to fraud.
The misbranding case stems from the promotion of Botox for uses for which it had not been approved between 2000 and 2005, the company said.
During that time, its marketing resulted in uses for headache, pain, spasticity, and juvenile cerebral palsy. Some of those uses were subsequently approved or are being considered.
The Justice Department said the settlement comes following a lengthy civil and criminal probe.