FDA — authorised 11 June 2020
- Application: BLA761142
- Marketing authorisation holder: VIELA BIO
- Local brand name: UPLIZNA
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised UPLIZNA on 11 June 2020
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 June 2020.
VIELA BIO holds the US marketing authorisation.