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Violation Tracker Individual Record

Company: Eisai Inc.
Current Parent Company: Eisai
Penalty: $11,000,000
Year: 2010
Date: December 15, 2010
Offense Group: healthcare-related offenses
Primary Offense: off-label or unapproved promotion of medical products
Violation Description: Irish pharmaceutical manufacturer Elan Corporation PLC and its U.S. subsidiary Elan Pharmaceuticals Inc. agreed to pay more than $203 million to resolve criminal and civil liability arising from the illegal promotion of the epilepsy drug Zonegran. In a separate civil settlement, Japanese drug marketer Eisai Inc., which purchased the drug from Elan, will pay $11 million to resolve civil liability for off-label marketing of Zonegran.
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: Japan
Ownership Structure of Current Parent: publicly traded
Major Industry of Current Parent: pharmaceuticals
Specific Industry of Current Parent: pharmaceuticals
Source of Data: (click here)
Source Notes: If an online information source is not working, check the Violation Tracker Data Sources page for an updated link.
Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.