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Violation Tracker Individual Record

Company: OSI Pharmaceuticals LLC
Current Parent Company: Astellas Pharma
Penalty: $67,000,000
Year: 2016
Date: June 6, 2016
Offense Group: government-contracting-related offenses
Primary Offense: False Claims Act and related
Secondary Offense: drug or medical equipment safety violation
Mega-Scandal: Pharmaceutical Hazards
Violation Description: Pharmaceutical companies Genentech Inc. and OSI Pharmaceuticals LLC agreed to pay $67 million to resolve False Claims Act allegations that they made misleading statements about the effectiveness of the drug Tarceva to treat non-small cell lung cancer. Genentech, located in South San Francisco, California, and OSI Pharmaceuticals, located in Farmingdale, New York, co-promote Tarceva, which is approved to treat certain patients with non-small cell lung cancer or pancreatic cancer. OSI Pharmaceuticals LLC is the successor to OSI Pharmaceuticals Inc., which was acquired by Astellas Holding US Inc. in 2010 and converted to a limited liability company in 2011.
Level of Government: federal
Action Type: agency action
Agency: Justice Department Civil Division
Civil or Criminal Case: civil
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.