FDA — authorised 15 November 2019
- Application: BLA761128
- Marketing authorisation holder: NOVARTIS PHARMS CORP
- Local brand name: ADAKVEO
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA authorised ADAKVEO on 15 November 2019
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 15 November 2019; FDA has authorised it.
NOVARTIS PHARMS CORP holds the US marketing authorisation.