FDA approves Astellas' Mycamine sNDA

28 January 2008

Japan's Astellas Pharma says that the US Food and Drug Administration has approved a supplemental New Drug Application that sought clearance for use of the antibiotic Mycamine (micafungin sodium) in the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses. The agency had previously licensed the drug for esophageal candidiasis and the prophylactic treatment of candida in patients undergoing hematopoietic stem-cell transplantation.

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