Violation Tracker Individual Record

Company: 
Novo Nordisk Inc.
Current Parent Company: 
Novo A/S
Penalty: 
$58,650,000
Year: 
2017
Date: 
September 5, 2017
Primary Offense: 
False Claims Act
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 Parent: 
Denmark
Ownership Structure of Parent: 
privately held
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.