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# FDA Approves Astellas Mycamine sNDA
- URL: https://www.fdaweb.com/fda-approves-astellas-mycamine-snda/
- Published: 2020-01-08T12:00:00.000Z
- Updated: 2026-09-14T15:57:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145799

FDA has approved an Astellas Pharma supplemental NDA for Mycamine (micafungin for injection) for treating candidemia, acute disseminated candidiasis, *Candida* peritonitis and abscesses without meningoencephalitis or ocular dissemination in pediatric patients younger than four months of age. Approval was based on data from 168 pediatric patients younger than four months of age who received varying doses of Mycamine in nine clinical trials, the company says. Mycamine was approved for adults for *Candida* infections in 2005, and in 2013 for pediatric patients aged four months and older.