FDA — authorised 17 December 2020
- Application: BLA761140
- Marketing authorisation holder: AMGEN INC
- Local brand name: RIABNI
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised RIABNI on 17 December 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 17 December 2020; FDA has authorised it.
AMGEN INC holds the US marketing authorisation.