Irvine-based Allergan Inc. is paying $600 million and pleading guilty to a misdemeanor charge to settle a government probe of its marketing practices for flagship drug Botox.
Allergan is paying $375 million to settle a charge that Botox was “misbranded” and didn’t include labeling information for treating conditions suggested by the company’s marketing.
Botox marketing resulted in use of the drug for unapproved conditions from 2000 to 2005, according to the settlement.
Allergan also is paying $225 million to resolve a related Justice Department lawsuit.
The company called the lawsuit meritless and is settling it “in the best interest of its stockholders.”
Botox is approved for temporarily removing wrinkles, treating muscle and neck spasms, eye muscle disorders and excessive underarm sweating.
The drug had second-quarter sales of $360 million, or about a third of Allergan’s $1 billion in sales for the three months.
The government probe had to do with what is known as off-label usage of Botox to treat headaches, pain, muscle stiffness and juvenile cerebral palsy.
Once a drug is approved by regulators, doctors can prescribe it for any condition they see fit. But drug makers can’t promote the drug for unapproved uses.
Botox’s fame as a wrinkle remover came from off-label use by cosmetic doctors who used it for years for treating wrinkles before regulators approved it for that use in 2002.
Last fall, Allergan filed a lawsuit against the federal government to allow it to provide doctors with details about other Botox uses. The company is dropping the lawsuit as part of the settlement.
Some company watchers believe the settlement could help speed the expected approval of Botox to treat migraines and other conditions.
The FDA could sign off on Botox for migraines by the end of October. In July, British regulators cleared Allergan to market Botox for migraines there.
Allergan expects to report $610 million to $615 million in charges from the settlement in the third quarter with more charges expected in the fourth quarter.
