FDA — authorised 12 May 2022
- Application: NDA215446
- Marketing authorisation holder: SHIONOGI
- Local brand name: RADICAVA ORS
- Indication: SUSPENSION — ORAL
- Status: approved
FDA authorised Radicava ORS on 12 May 2022
Yes. FDA authorised it on 12 May 2022.
SHIONOGI holds the US marketing authorisation.