FDA approves Astellas drug for fungal infections in children

Mycamine approved for various Candida fungus-related indications

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Astellas Pharma for treating fungal infections in children.

Astellas announced the approval of Mycamine (micafungin sodium) injection for children ages 4 months and older with various infections caused by Candida fungus, the same fungus that causes athlete's foot, and also to prevent Candida infections in patients undergoing hematopoietic stem cell transplants. The new uses for the drug were approved under a supplemental new drug application, or sNDA, as the drug itself is already approved and on the market.

"We are pleased with FDA's approval of Mycamine for use in pediatric patients 4 months and older," Astellas chief medical officer Sef Kurstjens said. "This expanded indication supports the safety and efficacy of Mycamine and delivers on our mission to provide treatments that can help to improve patient care."


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