FDA — authorised 5 December 2017
- Application: NDA209637
- Marketing authorisation holder: NOVO
- Local brand name: OZEMPIC
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Semaglutide 1.0 mg in United States
FDA authorised Semaglutide 1.0 mg on 5 December 2017
Marketing authorisations
FDA
- Status: approved
Semaglutide 1.0 mg 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 Semaglutide 1.0 mg approved in United States?
Yes. FDA authorised it on 5 December 2017; FDA has authorised it.
Who is the marketing authorisation holder for Semaglutide 1.0 mg in United States?
NOVO holds the US marketing authorisation.