Sept. 01--Pharmaceutical manufacturer Allergan has reached a $600 million settlement with federal prosecutors in Atlanta and agreed to plead guilty for its off-label promotion of Botox.

Under the agreement, Allergan will pay a criminal fine and forfeiture totaling $375 million and pay a civil settlement of $225 million.

Botox is best known for its ability to smooth out wrinkles, and the Food and Drug Administration has approved the product only for rare conditions, U.S. Attorney Sally Yates said in a statement released Wednesday.

"Yet Allegan made it a top corporate priority to maximize sales of far more lucrative off-label uses that were not approved by FDA," Yates said. "Allergan further demanded tremendous growth in these off-label sales year after year, even when there was little clinical evidence that these uses were effective."

A criminal complaint filed against Allergan Wednesday in U.S. District Court in Atlanta said the company, headquartered in Irvine, Calif., unlawfully promoted Botox for headaches, pain, spasticity and juvenile cerebral palsy from 2000 to 2005.

Allergan has agreed to plead guilty to a misdemeanor charge of misbranding Botox in violation of the Food, Drug and Cosmetic Act, federal authorities said. The settlement is not final until approved by a federal judge.

The settlement is the fifth largest amount paid by a single defendant in a pharmaceutical off-label marketing case, the Justice Department said. It is the largest settlement in history for the U.S. Attorney's Office for the Northern District of Georgia.

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