FDA — authorised 9 June 2025
- Application: BLA761103
- Marketing authorisation holder: PFIZER INC
- Status: approved
🇺🇸 Mabthera in United States
FDA authorised Mabthera on 9 June 2025
Marketing authorisation
Mabthera 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 Mabthera approved in United States?
Yes. FDA authorised it on 9 June 2025.
Who is the marketing authorisation holder for Mabthera in United States?
PFIZER INC holds the US marketing authorisation.