FDA — authorised 12 February 2013
- Application: ANDA201511
- Marketing authorisation holder: PH HEALTH
- Local brand name: MAFENIDE ACETATE
- Indication: FOR SOLUTION — TOPICAL
- Status: approved
🇺🇸 MAFENIDE ACETATE in United States
FDA authorised MAFENIDE ACETATE on 12 February 2013 · 12 US adverse-event reports
Marketing authorisations
FDA — authorised 31 July 2017
- Application: ANDA206716
- Marketing authorisation holder: INGENUS PHARMS LLC
- Local brand name: MAFENIDE ACETATE
- Indication: FOR SOLUTION — TOPICAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 12
Most-reported reactions
- Drug Ineffective — 2 reports (16.67%)
- Multiple Organ Dysfunction Syndrome — 2 reports (16.67%)
- Aspergillus Infection — 1 report (8.33%)
- Bradycardia — 1 report (8.33%)
- Drug Effective For Unapproved Indication — 1 report (8.33%)
- Drug Ineffective For Unapproved Indication — 1 report (8.33%)
- Drug Resistance — 1 report (8.33%)
- Dry Skin — 1 report (8.33%)
- Erythema — 1 report (8.33%)
- Haemolysis — 1 report (8.33%)
MAFENIDE ACETATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is MAFENIDE ACETATE approved in United States?
Yes. FDA authorised it on 12 February 2013; FDA authorised it on 31 July 2017; FDA has authorised it.
Who is the marketing authorisation holder for MAFENIDE ACETATE in United States?
PH HEALTH holds the US marketing authorisation.