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news.Astellas Pharma has reported that the FDA has approved their supplemental new drug application seeking approval for the use of Mycamine for injection in the treatment of patients with Candidemia, acute disseminated candidiasis, candida peritonitis and abscesses.
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Mycamine was approved in 2005 for the treatment of patients with esophageal candidiasis and is the only echinocandin approved for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation.
Yoshihiko Hatanaka, president and CEO of Astellas Pharma, said: “The FDA’s approval of this sNDA further confirms the safety and efficacy profile of Mycamine and its importance in the treatment of candidemia and other Candida infections.”