FDA — authorised 23 June 2023
- Application: NDA215830
- Marketing authorisation holder: PFIZER
- Local brand name: LITFULO
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Litfulo in United States
FDA authorised Litfulo on 23 June 2023
Marketing authorisations
FDA
- Status: approved
Litfulo in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Litfulo approved in United States?
Yes. FDA authorised it on 23 June 2023; FDA has authorised it.
Who is the marketing authorisation holder for Litfulo in United States?
PFIZER holds the US marketing authorisation.