A settlement has been reached in a whistleblower class action lawsuit brought against Astellas Pharma US Inc who is accused of marketing and promoting the drug Mycamine for pediatric use, which was not a medically accepted indication and, therefore, not covered by federal health care programs.
As part of the $7.3 million settlement, the federal government will receive $4.2 million, and state Medicaid programs will receive $3.1 million. The whistleblower will receive a $708,852 share of the government's amount.
The complaint was originally filed in March of 2010 and alleged specifically that, between 2005 and 2010, Astellas marketed and promoted the sale of Mycamine for pediatric use. During this time period, the FDA approved Mycamine to treat adult patients suffering from serious and invasive infections caused by the fungus Candida, including infections in the esophagus, the blood and the abdomen, and to prevent Candida infections in adults undergoing stem cell transplants. From 2005 through June 2013, however, Mycamine was not approved to treat pediatric patients for any use.
