TheraRadar

Pharma Intelligence, Simplified

Data updated: Mar 10, 2026

SULFAMYLON

MAFENIDE ACETATE
Dermatology Approved 1969-01-24
2
Indications
--
Phase 3 Trials
1
Priority Reviews
57
Years on Market

Details

Status
Prescription
First Approved
1969-01-24
Routes
TOPICAL
Dosage Forms
CREAM, FOR SOLUTION

Companies

Active Ingredient: MAFENIDE ACETATE

SULFAMYLON Approval History

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What SULFAMYLON Treats

1 indications

SULFAMYLON is approved for 1 conditions since its original approval in 1969. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Burns
Source: FDA Label
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

SULFAMYLON FDA Label Details

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Indications & Usage

FDA Label (PDF)

SULFAMYLON Cream is a topical agent indicated for adjunctive therapy of patients with second- and third-degree burns.

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.