FDA — authorised 13 May 2022
- Marketing authorisation holder: ELI LILLY CO
- Status: approved
🇺🇸 Mounjaro in United States
FDA authorised Mounjaro on 13 May 2022
Marketing authorisations
FDA — authorised 13 May 2022
- Application: NDA215866
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: MOUNJARO (AUTOINJECTOR)
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 8 November 2023
- Application: NDA217806
- Marketing authorisation holder: ELI LILLY AND CO
- Local brand name: ZEPBOUND (AUTOINJECTOR)
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Mounjaro in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Mounjaro approved in United States?
Yes. FDA authorised it on 13 May 2022; FDA authorised it on 13 May 2022; FDA authorised it on 8 November 2023.
Who is the marketing authorisation holder for Mounjaro in United States?
ELI LILLY CO holds the US marketing authorisation.