FDA — authorised 21 November 2016
- Application: BLA208583
- Marketing authorisation holder: NOVO
- Local brand name: XULTOPHY 100/3.6
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 IDegLira in United States
FDA authorised IDegLira on 21 November 2016
Marketing authorisations
FDA
- Status: approved
IDegLira in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is IDegLira approved in United States?
Yes. FDA authorised it on 21 November 2016; FDA has authorised it.
Who is the marketing authorisation holder for IDegLira in United States?
NOVO holds the US marketing authorisation.