FDA — authorised 6 August 2024
- Application: NDA218784
- Marketing authorisation holder: SERVIER
- Local brand name: VORANIGO
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Voranigo on 6 August 2024
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 6 August 2024; FDA has authorised it.
SERVIER holds the US marketing authorisation.