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Novartis agrees to $422.5m in fines

US Attorney Zane Memeger said Novartis illegally marketed Trileptal as a treatment for bipolar disorder and nerve pain. US Attorney Zane Memeger said Novartis illegally marketed Trileptal as a treatment for bipolar disorder and nerve pain.
Associated Press / October 1, 2010

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PHILADELPHIA — Novartis Pharmaceuticals Corp. will pay $422.5 million in penalties for marketing an epilepsy medicine for unapproved uses and for paying kickbacks to doctors to prescribe it and five other drugs, federal officials said yesterday.

The company agreed to plead guilty to distribution of a misbranded drug and pay a criminal fine and forfeiture totaling $185 million in the case involving Trileptal, US Attorney Zane Memeger said.

Novartis will also pay $237.5 million to resolve civil liabilities over kickbacks and off-label marketing of Trileptal, an anti-epileptic medicine.

The drug maker illegally marketed Trileptal as a treatment for bipolar disorder and nerve pain, sending its sales force to the offices of neurologists, psychiatrists, and pain specialists, Memeger said.

While doctors are permitted to prescribe medications for off-label uses, pharmaceutical companies are not allowed to market or promote drugs for uses not approved by the Food and Drug Administration. Prosecutors do not allege any patients were harmed.

The agreement resolves four whistle-blower lawsuits filed by former employees who will share $25.6 million of the penalty money.