- Associated Press - Thursday, September 30, 2010

WASHINGTON (AP) - Novartis Pharmaceuticals Corp. has agreed to pay $422.5 million stemming from illegal marketing of the anti-epileptic drug Trileptal and five other drugs, the Justice Department announced Thursday.

The department said the company based in East Hanover, N.J., will plead guilty in Philadelphia to a misdemeanor in connection with off-label promotion of Trileptal.

The company will pay $185 million in a criminal fine and forfeiture because the company urged the use of Trileptal for psychiatric and pain uses, the government said.

Once a drug is approved by federal regulators, a manufacturer may not market it for unspecified uses.

The other drugs involved in the case are Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.

Novartis has agreed to pay $237.5 million to resolve civil allegations of unlawfully marketing the six drugs.

The agreement between the government and Novartis settles allegations that the company paid kickbacks to health care professionals to persuade them to prescribe the six drugs.

Whistleblowers, all formerly employees of Novartis, played an important role in developing the case; they filed four lawsuits under the False Claims Act, which enables private citizens with knowledge of fraud to go to court. In the current case, the whistleblowers will receive $25 million from the federal share of the money collected.

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