Violation Tracker Individual Record

Company: 
Novartis Pharmaceuticals Corporation
Current Parent Company: 
Novartis
Penalty: 
$422,500,000
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.

Year: 
2010
Date: 
September 30, 2010
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.