FDA — authorised 7 January 2019
- Application: ANDA209018
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: INGENOL MEBUTATE
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Picato in United States
FDA authorised Picato on 7 January 2019 · 469 US adverse-event reports
Marketing authorisations
FDA — authorised 9 January 2019
- Application: ANDA209019
- Marketing authorisation holder: PADAGIS ISRAEL
- Local brand name: INGENOL MEBUTATE
- Indication: GEL — TOPICAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA209086
- Marketing authorisation holder: ACTAVIS LABS
- Local brand name: INGENOL MEBUTATE
- Indication: GEL — TOPICAL
- 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: 469
Most-reported reactions
- Application Site Erythema — 98 reports (20.9%)
- Application Site Vesicles — 72 reports (15.35%)
- Application Site Pain — 68 reports (14.5%)
- Drug Administered At Inappropriate Site — 59 reports (12.58%)
- Application Site Exfoliation — 46 reports (9.81%)
- Application Site Scab — 30 reports (6.4%)
- Incorrect Drug Administration Duration — 29 reports (6.18%)
- Application Site Swelling — 28 reports (5.97%)
- Application Site Pruritus — 22 reports (4.69%)
- Drug Administration Error — 17 reports (3.62%)
Picato in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is Picato approved in United States?
Yes. FDA authorised it on 7 January 2019; FDA authorised it on 9 January 2019; FDA has authorised it.
Who is the marketing authorisation holder for Picato in United States?
PADAGIS ISRAEL holds the US marketing authorisation.