FDA — authorised 24 December 2002
- Application: NDA021470
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: FINACEA
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Finacea in United States
FDA authorised Finacea on 24 December 2002 · 3,383 US adverse-event reports
Marketing authorisations
FDA — authorised 29 July 2015
- Application: NDA207071
- Marketing authorisation holder: LEO PHARMA AS
- Local brand name: FINACEA
- Indication: AEROSOL, FOAM — 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: 3,383
Most-reported reactions
- Drug Ineffective — 391 reports (11.56%)
- Paraesthesia — 359 reports (10.61%)
- Gastrooesophageal Reflux Disease — 347 reports (10.26%)
- Abdominal Pain Upper — 345 reports (10.2%)
- Hypoaesthesia — 338 reports (9.99%)
- Blepharospasm — 325 reports (9.61%)
- Off Label Use — 324 reports (9.58%)
- Pain — 322 reports (9.52%)
- Epilepsy — 316 reports (9.34%)
- Taste Disorder — 316 reports (9.34%)
Finacea in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Dermatology approved in United States
Frequently asked questions
Is Finacea approved in United States?
Yes. FDA authorised it on 24 December 2002; FDA authorised it on 29 July 2015; FDA has authorised it.
Who is the marketing authorisation holder for Finacea in United States?
LEO PHARMA AS holds the US marketing authorisation.