FDA — authorised 23 May 2023
- Application: BLA761219
- Marketing authorisation holder: CELLTRION
- Local brand name: YUFLYMA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 YUFLYMA in United States
FDA authorised YUFLYMA on 23 May 2023
Marketing authorisations
FDA
- Status: approved
YUFLYMA 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 YUFLYMA approved in United States?
Yes. FDA authorised it on 23 May 2023; FDA has authorised it.
Who is the marketing authorisation holder for YUFLYMA in United States?
CELLTRION holds the US marketing authorisation.