Treats Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses. ANDA 216438, held by Biocon Pharma. Micafungin Sodium.
As of Nov 15, 2026, ANDA 216438 (Micafungin Sodium), held by Biocon Pharma, was first approved by FDA on May 29, 2024, with 0 approved supplements 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 |
|---|---|---|---|
| May 29, 2024 | 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 |
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
