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Violation Tracker Individual Record

Company: Novo Nordisk Inc.
Current Parent CompanyNovo Holdings A/S
Parent at the Time of the Penalty Announcement subscribe to see this data field
Penalty: $58,650,000
Year: 2017
Date: September 5, 2017
Offense Group: government-contracting-related offenses
Primary Offense: False Claims Act and related
Secondary Offense: drug or medical equipment safety violation
Violation Description: Novo Nordisk Inc. agreed to pay $58.65 million to resolve allegations that the company failed to comply with the FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) for its Type II diabetes medication Victoza. The resolution included disgorgement of $12.15 million for alleged violations of the Federal Food, Drug, and Cosmetic Act from 2010 to 2012 and a payment of $46.5 million for alleged violations of the False Claims Act from 2010 to 2014.
Level of Government: federal
Action Type: agency action
Agency: Justice Department Civil Division
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)
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Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.