FDA — authorised 4 June 2021
- Application: NDA215256
- Marketing authorisation holder: NOVO
- Local brand name: WEGOVY
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Wegovy ® in United States
FDA authorised Wegovy ® on 4 June 2021
Marketing authorisations
FDA — authorised 22 December 2025
- Application: NDA218316
- Marketing authorisation holder: NOVO
- Local brand name: WEGOVY
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Wegovy ® 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 Wegovy ® approved in United States?
Yes. FDA authorised it on 4 June 2021; FDA authorised it on 22 December 2025; FDA has authorised it.
Who is the marketing authorisation holder for Wegovy ® in United States?
NOVO holds the US marketing authorisation.