FDA — authorised 2 October 2025
- Application: BLA761377
- Marketing authorisation holder: CELLTRION INC
- Local brand name: EYDENZELT
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 EYDENZELT in United States
FDA authorised EYDENZELT on 2 October 2025
Marketing authorisations
FDA
- Status: approved
EYDENZELT 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 EYDENZELT approved in United States?
Yes. FDA authorised it on 2 October 2025; FDA has authorised it.
Who is the marketing authorisation holder for EYDENZELT in United States?
CELLTRION INC holds the US marketing authorisation.