FDA — authorised 7 July 2005
- Application: NDA021794
- Marketing authorisation holder: ALMIRALL
- Local brand name: ACZONE
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 dapsone gel in United States
FDA authorised dapsone gel on 7 July 2005 · 32 US adverse-event reports
Marketing authorisations
FDA — authorised 24 February 2016
- Application: NDA207154
- Marketing authorisation holder: ALMIRALL
- Local brand name: ACZONE
- Indication: GEL — 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: 32
Most-reported reactions
- Condition Aggravated — 4 reports (12.5%)
- Erythema — 4 reports (12.5%)
- Feeling Hot — 4 reports (12.5%)
- Flushing — 4 reports (12.5%)
- Skin Burning Sensation — 4 reports (12.5%)
- Burning Sensation — 3 reports (9.38%)
- Pruritus — 3 reports (9.38%)
- Drug Ineffective — 2 reports (6.25%)
- Pain Of Skin — 2 reports (6.25%)
- Rebound Effect — 2 reports (6.25%)
dapsone gel 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 dapsone gel approved in United States?
Yes. FDA authorised it on 7 July 2005; FDA authorised it on 24 February 2016; FDA has authorised it.
Who is the marketing authorisation holder for dapsone gel in United States?
ALMIRALL holds the US marketing authorisation.