FLUOROURACIL
Details
- Status
- Prescription
- First Approved
- 1962-04-25
- Routes
- TOPICAL, Injection, INJECTION
- Dosage Forms
- SOLUTION, Injectable, INJECTABLE, CREAM
Companies
FLUOROURACIL Approval History
What FLUOROURACIL Treats
3 indicationsFLUOROURACIL is approved for 3 conditions since its original approval in 1962. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Actinic Keratosis
- Solar Keratosis
- Basal Cell Carcinoma
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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.
FLUOROURACIL FDA Label Details
ProIndications & Usage
FDA Label (PDF)Fluorouracil Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success w...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.