Allergan to pay $600 million to settle US probe on anti-wrinkle treatment drug
02 September 2010
Multi-specialty health care products maker Allergan Inc. yesterday agreed to pay $600 million and pleaded guilty to settle a US government probe into the marketing of off-label uses of its antiwrinkle treatment drug Botox.
California-based Allergan pleaded guilty to a single misdemeanor "misbranding" charge covering the period 2000 through 2005 and agreed to pay to the US government $375 million and also pay $225 million to resolve civil claims from the Justice Department.
Botox has been approved by the US Food & Drug Administration (FDA) for temporarily removing wrinkles, treating muscle and neck spasms, eye muscle disorders and excessive underarm sweating.
The government probe is for Allergan selling Botox for off-lable usage to treat headache, pain, spasticity and juvenile cerebral palsy.
These uses were off-lable during the relevant time frame and thus the lableing for Botox did not bear directions for these intended uses, resulting in the product being misbranded, Allergan admitted.
Although Botox is approved in 70 countries around the world, including Japan, to treat symptoms associated with juvenile cerebral palsy, it is currently off-lable in the US.