FDA — authorised 19 November 2024
- Application: ANDA206697
- Marketing authorisation holder: AMNEAL
- Local brand name: EXENATIDE SYNTHETIC
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 GLP-1 analogs in United States
FDA authorised GLP-1 analogs on 19 November 2024
Marketing authorisations
FDA — authorised 22 July 2025
- Application: ANDA215421
- Marketing authorisation holder: LUPIN
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 27 August 2025
- Application: ANDA214568
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 14 January 2026
- Application: ANDA217590
- Marketing authorisation holder: ORBICULAR
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 24 February 2026
- Application: ANDA217063
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 11 March 2026
- Application: ANDA215245
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
FDA — authorised 30 March 2026
- Application: ANDA212552
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: LIRAGLUTIDE
- Indication: SOLUTION — SUBCUTANEOUS
- Status: approved
Other Diabetes approved in United States
Frequently asked questions
Is GLP-1 analogs approved in United States?
Yes. FDA authorised it on 19 November 2024; FDA authorised it on 22 July 2025; FDA authorised it on 27 August 2025.
Who is the marketing authorisation holder for GLP-1 analogs in United States?
AMNEAL holds the US marketing authorisation.