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Mafenide

Generic Name
Mafenide
Brand Names
Sulfamylon
Drug Type
Small Molecule
Chemical Formula
C7H10N2O2S
CAS Number
138-39-6
Unique Ingredient Identifier
58447S8P4L

Overview

Mafenide is a sulfonamide-type antimicrobial agent used to treat severe burns. It acts by reducing the bacterial population present in the burn tissue and promotes healing of deep burns. In 1998, mafenide acetate was approved under the FDA’s accelerated approval regulations. In November 2022, the use of mafenide acetate (powder for 5% topical solution) was withdrawn by the FDA due to an unresolved confirmatory study required to fulfill the accelerated approval requirements.

Background

Mafenide is a sulfonamide-type antimicrobial agent used to treat severe burns. It acts by reducing the bacterial population present in the burn tissue and promotes healing of deep burns. In 1998, mafenide acetate was approved under the FDA’s accelerated approval regulations. In November 2022, the use of mafenide acetate (powder for 5% topical solution) was withdrawn by the FDA due to an unresolved confirmatory study required to fulfill the accelerated approval requirements.

Indication

Indicated for use as an adjunctive topical antimicrobial agent to control bacterial infection when used under moist dressings over meshed autografts on excised burn wounds.

Associated Conditions

No associated conditions information available.

FDA Approved Products

Mafenide acetate
Manufacturer:Par Pharmaceutical, Inc.
Route:TOPICAL
Strength:50 g in 1 1
Approved: 2023/11/22
NDC:49884-902
SULFAMYLON
Manufacturer:Rising Pharma Holdings, Inc.
Route:TOPICAL
Strength:85 mg in 1 g
Approved: 2023/07/05
NDC:16571-723
Mafenide Acetate
Manufacturer:Ingenus Pharmaceuticals, LLC
Route:TOPICAL
Strength:50 g in 1 1
Approved: 2023/12/05
NDC:50742-310

Singapore Approved Products

No Singapore products found for this drug

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