FDA — authorised 16 January 2020
- Application: NDA213182
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: RYBELSUS
- Indication: TABLET — ORAL
- Status: approved
FDA authorised Semaglutide Pill on 16 January 2020
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Yes. FDA authorised it on 16 January 2020; FDA has authorised it.
NOVO NORDISK INC holds the US marketing authorisation.