FDA — authorised 23 June 2023
- Application: NDA215830
- Marketing authorisation holder: PFIZER
- Indication: Type 1 - New Molecular Entity
- Status: approved
🇺🇸 Litfulo in United States
FDA authorised Litfulo on 23 June 2023
Marketing authorisation
Litfulo 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 Litfulo approved in United States?
Yes. FDA authorised it on 23 June 2023.
Who is the marketing authorisation holder for Litfulo in United States?
PFIZER holds the US marketing authorisation.