ANCOBON
Details
- Status
- Prescription
- First Approved
- 1971-11-26
- Routes
- ORAL
- Dosage Forms
- CAPSULE
ANCOBON Approval History
What ANCOBON Treats
7 indicationsANCOBON is approved for 7 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Candidiasis
- Cryptococcosis
- Septicemia
- Endocarditis
- Urinary Tract Infection
- Pulmonary Infection
- Meningitis
ANCOBON Boxed Warning
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON....
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON.
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Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ANCOBON FDA Label Details
ProIndications & Usage
FDA Label (PDF)ANCOBON is indicated only in the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus . Candida: Septicemia, endocarditis and urinary system infections have been effectively treated with flucytosine. Limited trials in pulmonary infections justify the use of flucytosine. Cryptococcus: Meningitis and pulmonary infections have been treated effectively. Studies in septicemias and urinary tract infections are limited, but good responses have been reported. ANCOBON should be used in combination with amphotericin B for the treatment of systemic candidiasis and ...
WARNING Use with extreme caution in patients with impaired renal function. Close monitoring of hematologic, renal and hepatic status of all patients is essential. These instructions should be thoroughly reviewed before administration of ANCOBON....
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.