FDA — authorised 28 November 2018
- Application: BLA761088
- Marketing authorisation holder: CELLTRION INC
- Indication: Type 5 - New Formulation or New Manufacturer
- Status: approved
🇺🇸 TRUXIMA in United States
FDA authorised TRUXIMA on 28 November 2018
Marketing authorisation
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.
Who is the marketing authorisation holder for TRUXIMA in United States?
CELLTRION INC holds the US marketing authorisation.