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Data updated: May 26, 2026

SULFAMYLON (mafenide acetate)

Infectious Disease Approved 1969-01-24

SULFAMYLON is indicated for the treatment of Burns.

Source: FDA Label • RISING
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
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

RISING Viatris
Active Ingredient: MAFENIDE ACETATE

SULFAMYLON Approval History

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Original
New Indication
New Form
Label Update
28 FDA actions from 1969 to 2015
Jan 2015 SUPPL
Mfg · Manufacturing (CMC)
Jun 2013 SUPPL
Mfg · Manufacturing (CMC)
Dec 2002 SUPPL
Mfg · Manufacturing (CMC)

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

SULFAMYLON Competitive Set

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Indication competitors

4

Same indication, different mechanism — what else might this patient receive?

EPIOXA HD/EPIOXA KIT
GLAUKOS
2025 4 indic.
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA
GLAUKOS
2016 4 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to SULFAMYLON

3 of 4

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

EPIOXA HD/EPIOXA KIT
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Burns
OPTISON
ALBUMIN HUMAN
1 shared
GE HEALTHCARE
Shared indications:
Burns
PHOTREXA VISCOUS IN DEXTRAN 20%/PHOTREXA
RIBOFLAVIN 5'-PHOSPHATE SODIUM
1 shared
GLAUKOS
Shared indications:
Burns
View all 4 similar drugs Pro
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Key Completed Trials

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Trial Timeline

ClinicalTrials.gov ↗ Pro

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

Indications & Usage

FDA Label (PDF)

SULFAMYLON is indicated for the treatment of Burns.

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Data Sources

FDA Approval: NDA016763 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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