Violation Tracker Individual Record

Novartis Pharmaceuticals Corporation
Current Parent Company: 
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.

September 30, 2010
Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: 
civil and criminal
HQ Country of Parent: 
Ownership Structure of Parent: 
publicly traded
Major Industry of Parent: 
Specific Industry of Parent: 
Source Notes: 
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Parent company note: 
Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.