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FDA Approves Pediatric Indication for Astellas Pharma Inc's MYCAMINE (micafungin sodium) for Injection

Monday, 24 Jun 2013 07:00pm EDT 

Astellas Pharma Inc's subsidiary, Astellas Pharma US, Inc, announced that the U.S. Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (sNDA) for the use of MYCAMINE (micafungin sodium) for injection by intravenous infusion for the treatment of pediatric patients four months and older with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, esophageal candidiasis, and prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplants (HSCT). 

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