FDA — authorised 14 August 2023
- Application: BLA761345
- Marketing authorisation holder: PFIZER INC
- Local brand name: ELREXFIO
- Indication: SOLUTION — INJECTION
- Status: approved
FDA authorised Elrexfio on 14 August 2023
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 14 August 2023; FDA has authorised it.
PFIZER INC holds the US marketing authorisation.