FDA — authorised 28 November 2018
- Application: BLA761088
- Marketing authorisation holder: CELLTRION INC
- Status: supplemented
🇺🇸 Truxima in United States
FDA authorised Truxima on 28 November 2018
Marketing authorisations
FDA
- Status: approved
Truxima 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 Truxima approved in United States?
Yes. FDA authorised it on 28 November 2018; FDA has authorised it.
Who is the marketing authorisation holder for Truxima in United States?
CELLTRION INC holds the US marketing authorisation.