Treats serious infections caused by susceptible strains of Candida and/or Cryptococcus. Sold as Ancobon. Every FDA application for this active ingredient: 1 branded and 7 generic.
As of Nov 15, 2026, FDA lists 8 applications for Flucytosine (sold as Ancobon), first approved Nov 26, 1971, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Flucytosine | Part D | $5.5M | -36% | 1,604 |
| Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)Hiv, Cryptococcal Meningitis · David Boulware | Phase 2 / Phase 3 | Recruiting | Oct 30, 2024 |
| Liposomal Amphotericin B and Flucytosine Antifungal Strategy for Talaromycosis (LAmB-FAST)Talaromycosis · Duke University | Phase 3 | Not yet recruiting | Jul 29, 2024 |
| DB107-RRV, DB107-FC, and Radiation Therapy With or Without Temozolomide (TMZ) for High Grade GliomaHigh Grade Glioma, MGMT-Unmethylated Glioblastoma · University of California, San Francisco | Phase 1 / Phase 2 | Recruiting | Jul 16, 2024 |
| DB107-Retroviral Replicating Vector (RRV) Combined With DB107-Flucytosine (FC) in Patients With Recurrent Glioblastoma or Anaplastic AstrocytomaHigh Grade Glioma, Anaplastic Astrocytoma · Ashish Shah | Phase 2 | Recruiting | Feb 20, 2024 |
| Nov 26, 1971 | AncobonNDA 17001 · New molecular entity | Bausch | 24 | Marketed |
| Jun 28, 2011 | FlucytosineANDA 201566 | Sigmapharm Labs LLC | 2 | Marketed |
| Jul 7, 2017 | FlucytosineANDA 204652 | Novel Labs Inc | 0 | Marketed |
| Oct 17, 2017 | FlucytosineANDA 206550 | Hikma | 3 | Discontinued |
| Jun 18, 2018 | FlucytosineANDA 207536 | Strides Pharma | 0 | Discontinued |
| Apr 17, 2020 | FlucytosineANDA 212632 | Strides Pharma | 1 | Marketed |
| May 1, 2020 | FlucytosineANDA 213665 | Aurobindo Pharma Ltd | 1 | Marketed |
| Jul 23, 2025 | FlucytosineANDA 218005 | Pharmobedient | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Hikma
Strides Pharma