FDA — authorised 26 March 2019
- Application: NDA209884
- Marketing authorisation holder: NOVARTIS
- Local brand name: MAYZENT
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Mayzent on 26 March 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 26 March 2019.
NOVARTIS holds the US marketing authorisation.