FDA — authorised 23 January 2012
- Application: NDA202833
- Marketing authorisation holder: LEO LABS
- Local brand name: PICATO
- Indication: GEL — TOPICAL
- Status: approved
🇺🇸 Ingenol mebutate gel 0.05 % in United States
FDA authorised Ingenol mebutate gel 0.05 % on 23 January 2012
Marketing authorisation
Ingenol mebutate gel 0.05 % 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 Ingenol mebutate gel 0.05 % approved in United States?
Yes. FDA authorised it on 23 January 2012.
Who is the marketing authorisation holder for Ingenol mebutate gel 0.05 % in United States?
LEO LABS holds the US marketing authorisation.