FDA — authorised 4 June 2021
- Application: NDA215256
- Marketing authorisation holder: NOVO
- Local brand name: WEGOVY HD
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
🇺🇸 Glucagon-like peptide-1 receptor agonist：Semaglutide in United States
FDA authorised Glucagon-like peptide-1 receptor agonist：Semaglutide on 4 June 2021
Marketing authorisations
FDA
- Status: approved
FDA
- Application: ANDA220314
- Marketing authorisation holder: APOTEX INC
- Local brand name: SEMAGLUTIDE
- Indication: INJECTION — SOLUTION
- Status: approved
Glucagon-like peptide-1 receptor agonist：Semaglutide 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 Glucagon-like peptide-1 receptor agonist：Semaglutide approved in United States?
Yes. FDA authorised it on 4 June 2021; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for Glucagon-like peptide-1 receptor agonist：Semaglutide in United States?
NOVO holds the US marketing authorisation.