FDA — authorised 24 August 2023
- Application: BLA761322
- Marketing authorisation holder: SANDOZ INC
- Local brand name: TYRUKO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised TYRUKO on 24 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 24 August 2023; FDA has authorised it.
SANDOZ INC holds the US marketing authorisation.