Basic Search  |  Summaries  |  Advanced Search

Violation Tracker Individual Record

Company: Novo Nordisk Inc.
Current Parent Company: Novo Holdings A/S
Parent at the Time of the Penalty Announcement:  subscribe to see this data field
Penalty: $25,000,000
Year: 2011
Date: June 10, 2011
Offense Group: healthcare-related offenses
Primary Offense: off-label or unapproved promotion of medical products
Secondary Offense: drug or medical equipment safety violation
Mega-Scandal: Pharmaceutical Hazards
Violation Description: Novo Nordisk Inc., a Danish pharmaceutical manufacturer, has agreed to pay $25 million to resolve its civil liability arising from the illegal promotion of its hemostasis management drug, NovoSeven. The Food and Drug Administration (FDA) approved NovoSeven to treat certain bleeding disorders in hemophiliacs.
Level of Government: federal
Action Type: agency action
Agency: Food and Drug Administration referral to the Justice Department
Civil or Criminal Case: civil
HQ Country of Current Parent: Denmark
Ownership Structure of Current Parent: privately held
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.