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Violation Tracker Individual Record

Company: Novartis Pharmaceuticals Corporation
Current Parent CompanyNovartis
Parent at the Time of the Penalty Announcement subscribe to see this data field
Penalty: $422,500,000
Year: 2010
Date: September 30, 2010
Offense Group: healthcare-related offenses
Primary Offense: off-label or unapproved promotion of medical products
Violation Description: Novartis Pharmaceuticals Corporation agreed to pay $422.5 million to resolve criminal and civil liability arising from the illegal marketing of certain pharmaceutical products. According to the agreement reached with the government, the East Hanover, N.J.-based company was to plead guilty to a misdemeanor and pay a $185 million combined criminal fine and forfeiture for the off-label promotion of Trileptal in violation of the Food, Drug and Cosmetic Act. The Food and Drug Administration (FDA) approved Trileptal as an anti-epileptic drug, for the treatment of partial seizures, but not for any psychiatric, pain or other uses. Once a pharmaceutical is approved by the FDA, a manufacturer may not market or promote it for any use not specified in its new drug application.
Level of Government: federal
Action Type: agency action
Agency: Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: civil and criminal
HQ Country of Current Parent: Switzerland
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: pharmaceuticals
Specific Industry of Current Parent: pharmaceuticals
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Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.