Mycamine FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 28, 2021.
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 timeline for Mycamine
Further information
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