FDA — authorised 21 November 2018
- Application: NDA210656
- Marketing authorisation holder: PFIZER
- Local brand name: DAURISMO
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Daurismo on 21 November 2018
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 21 November 2018.
PFIZER holds the US marketing authorisation.