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Mycamine Approval History

FDA Approved: Yes (First approved March 16, 2005)
Brand name: Mycamine
Generic name: micafungin sodium
Dosage form: for Injection
Company: Fujisawa Healthcare, Inc.
Treatment for: Esophageal Candidiasis, Fungal Infection Prophylaxis, Candidemia

Mycamine (micafungin sodium) is an echinocandin antifungal agent used for the prophylaxis of Candida infections in patients undergoing hematopoietic stem cell transplantation, for the treatment of esophageal candidiasis and candidemia.

Development History and FDA Approval Process for Mycamine

Jun 24, 2013Approval FDA Approves Pediatric Indication for Astellas' Mycamine (micafungin sodium) for Injection
Jan 23, 2008Approval FDA Approves Additional Indication for Astellas' Mycamine
Mar 16, 2005Approval Mycamine Approved for Candida Infections
Apr 27, 2004Fujisawa Healthcare, Inc. Submits NDA For Mycamine For Treatment Of Esophageal Candidiasis

Further information

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