🇺🇸 Rybelsus in United States

FDA authorised Rybelsus on 20 September 2019

Marketing authorisations

FDA — authorised 20 September 2019

  • Application: NDA213051
  • Marketing authorisation holder: NOVO
  • Status: supplemented

FDA

  • Status: approved

Other Metabolic approved in United States

Frequently asked questions

Is Rybelsus approved in United States?

Yes. FDA authorised it on 20 September 2019; FDA has authorised it.

Who is the marketing authorisation holder for Rybelsus in United States?

NOVO holds the US marketing authorisation.