Violation Tracker Individual Record
Company:
Novartis Pharmaceuticals Corporation
Current Parent Company:
Novartis
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 Parent:
Switzerland
Ownership Structure of Parent:
publicly traded
Major Industry of Parent:
pharmaceuticals
Specific Industry of Parent:
pharmaceuticals
Source Notes:
If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Parent company note:
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.
