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Sulfamylon® For 5 % Topical Solution
Sulfamylon® For 5 % Topical Solution is a Sulfonamide antimicrobial agent Small molecule drug developed by Mylan Inc.. It is currently FDA-approved for Adjunctive topical antimicrobial agent for second and third-degree burns. Also known as: mafenide acetate.
Mafenide acetate inhibits bacterial folic acid synthesis by competing with para-aminobenzoic acid, thereby exerting broad-spectrum antimicrobial activity against burn wound pathogens.
Sulfamylon 5% Topical Solution is a topical antimicrobial/antifungal medication used to treat burns. Its exact mechanism of action is unknown.
At a glance
| Generic name | Sulfamylon® For 5 % Topical Solution |
|---|---|
| Also known as | mafenide acetate |
| Sponsor | Mylan Inc. |
| Drug class | Sulfonamide antimicrobial agent |
| Target | Dihydropteroate synthase (bacterial folate synthesis pathway) |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Burn Care / Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Mafenide is a sulfonamide that acts as a competitive inhibitor of dihydropteroate synthase, disrupting bacterial folate metabolism and nucleic acid synthesis. It provides broad-spectrum coverage against gram-positive and gram-negative organisms commonly found in burn wounds, including Pseudomonas aeruginosa. The topical formulation allows direct application to burned tissue to prevent and treat wound infections.
Approved indications
- Adjunctive topical antimicrobial agent for second and third-degree burns
Common side effects
- Metabolic acidosis
- Hemolytic anemia
- Local pain or burning at application site
- Allergic reactions (rash, pruritus)
- Pulmonary edema
Key clinical trials
- Effects of Therapy With Sulfamylon® 5% Topical Solution Compared to a Historical Control Group (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Sulfamylon® For 5 % Topical Solution CI brief — competitive landscape report
- Sulfamylon® For 5 % Topical Solution updates RSS · CI watch RSS
- Mylan Inc. portfolio CI
Frequently asked questions about Sulfamylon® For 5 % Topical Solution
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Related
- Drug class: All Sulfonamide antimicrobial agent drugs
- Target: All drugs targeting Dihydropteroate synthase (bacterial folate synthesis pathway)
- Manufacturer: Mylan Inc. — full pipeline
- Therapeutic area: All drugs in Dermatology / Burn Care / Infectious Disease
- Indication: Drugs for Adjunctive topical antimicrobial agent for second and third-degree burns
- Also known as: mafenide acetate
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing