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Violation Tracker Individual Record

Company: Astellas Pharma US Inc.
Current Parent CompanyAstellas Pharma
Parent at the Time of the Penalty Announcement subscribe to see this data field
Penalty: $7,300,000
Year: 2014
Date: April 16, 2014
Offense Group: government-contracting-related offenses
Primary Offense: False Claims Act and related
Secondary Offense: off-label or unapproved promotion of medical products
Violation Description: Astellas Pharma US Inc. agreed to pay $7.3 million to resolve allegations that it violated the False Claims Act in connection with its marketing and promotion of the drug Mycamine for pediatric use, which had not received FDA approval.
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)
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Current parent company note: Parent-subsidiary relationship is current as of the most recent revision listed in the Update Log.