Swiss pharma company Novartis is to pay $422.5 million (SFr415 million) to settle charges of improperly marketing its epilepsy drug Trileptal in the United States.This content was published on September 30, 2010 - 20:57
As part of the settlement its US subsidiary, Novartis Pharmaceuticals Corporation, will plead guilty to one violation of misbranding under the US Food, Drug and Cosmetic Act and pay a fine of $185 million for Trileptal.
The remainder is to resolve civil allegations, Zane Memeger, the US Attorney for the Eastern District of Pennsylvania, told a news conference on Thursday.
The penalties are the result of an investigation that found Novartis promoted Trileptal for unapproved uses, including pain and psychiatric conditions.
While doctors can prescribe any medicines as they see fit, pharmaceutical companies are only allowed to promote drugs for uses approved by the US Food and Drug Administration.
“That legal duty takes priority over generating profits,” Memeger said. “This prosecution demonstrates our continuing commitment to ensure that pharmaceutical companies comply with the law.”
The civil settlement also resolves claims that Novartis paid illegal payments to health care professionals to induce them to prescribe Trileptal and five other drugs - Diovan, Zelnorm, Sandostatin, Exforge and Tekturna.
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