Treats Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. ANDA 213261, held by Hikma. Micafungin Sodium.
As of Nov 15, 2026, ANDA 213261 (Micafungin Sodium), held by Hikma, was first approved by FDA on Jul 9, 2021, with 1 approved supplement and 0 published complete response letters.
Micafungin for Injection is indicated 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.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2021 | Original application | Approved | None posted |
| Micafungin SodiumEQ 50MG BASE/VIAL · injectable;intravenous | Micafungin Sodium | Rx |
| Micafungin SodiumEQ 100MG BASE/VIAL · injectable;intravenous | Micafungin Sodium | Rx |
| Jul 23, 2025 | Supplement 5Labeling · Standard review | Approved | None posted |
| Jul 9, 2021 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
