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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: Astellas Pharma US, Inc.
Treatment for: Esophageal Candidiasis, Fungal Infection Prophylaxis, Candidemia

Mycamine (micafungin sodium) is an echinocandin antifungal agent indicated for the treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, esophageal candidiasis, and for the prevention of candida Infections in patients undergoing Hematopoietic Stem Cell Transplantation (HSCT).

Mycamine is indicated in adult and pediatric patients for:

  • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
  • Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age.
  • Treatment of Esophageal Candidiasis in adult and pediatric patients 4 months of age and older.
  • Prophylaxis of Candida Infections in adult and pediatric patients 4 months of age and older undergoing Hematopoietic Stem Cell Transplantation (HSCT).

Development History and FDA Approval Process for Mycamine

DateArticle
Jan  8, 2020Approval FDA Approves Expanded Indication of Mycamine (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age
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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