Novartis Pharmaceuticals Corp. has agreed to pay $422.5 million in civil and criminal fines for promoting drugs for uses that had not been approved by the Food and Drug Administration, the U.S. Department of Justice announced Thursday in Philadelphia.
The corporation is the U.S. subsidiary of Novartis AG, which is based in Switzerland.
Under the settlement, which requires approval by federal court in Philadelphia, Novartis agreed to plead guilty and pay a criminal fine of $185 million for off-label marketing of the antiepileptic drug Trileptal.
It also will pay $237.5 million in civil penalties for off-label marketing of that drug and for offering financial inducements for doctors to prescribe Trileptal and five other Novartis medicines - Diovan, Exforge, Tekturna, Zelnorm, and Sandostatin. The "kickbacks" included payments for speaker programs, advisory board memberships, entertainment, travel, and meals to encourage doctors to prescribe the drugs.