FDA — authorised 11 February 2021
- Application: BLA761181
- Marketing authorisation holder: REGENERON PHARMACEUTICALS
- Local brand name: EVKEEZA
- Indication: SOLUTION — INJECTION
- Status: approved
FDA authorised EVKEEZA on 11 February 2021
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 11 February 2021; FDA has authorised it.
REGENERON PHARMACEUTICALS holds the US marketing authorisation.