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news.Astellas Pharma US has reached an agreement with the US Department of Justice to resolve civil claims regarding the marketing of Mycamine (micafungin sodium) for injection.
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Under the agreement, Astellas will pay $7.3m to the settling parties.
The Department of Justice had investigated Astellas for alleged off-label promotion of MYCAMINE for pediatric use, a claim the company has consistently denied. MYCAMINE is an injectable drug used to treat or prevent certain serious fungal infections and, at the time of the investigation, had not yet been approved for pediatric use in the United States.
MYCAMINE received approval by the US Food and Drug Administration (FDA) in June, 2013 for use in children four months and older.
Astellas Pharma US CEO Masao Yoshida noted that the company cooperated fully with the US Government’s review of this matter, and the company is pleased to have reached a resolution.
"In keeping with our corporate commitment to conduct business with a high sense of ethics, our policy has always been to promote our products in accordance with FDA regulations," Yoshida added.
The efficacy of MYCAMINE against infections caused by fungi other than Candida has not been established.