Violation Tracker Individual Record

Company: 
Astellas Pharma US Inc.
Current Parent Company: 
Astellas Pharma
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 Parent: 
Japan
Ownership Structure of Parent: 
publicly traded
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.