FDA — authorised 28 April 2005
- Marketing authorisation holder: ASTRAZENECA AB
- Status: approved
🇺🇸 Byetta in United States
FDA authorised Byetta on 28 April 2005
Marketing authorisations
FDA — authorised 21 December 2022
- Application: NDA021773
- Marketing authorisation holder: ASTRAZENECA AB
- Indication: Labeling
- Status: approved
FDA — authorised 19 November 2024
- Application: ANDA206697
- Marketing authorisation holder: AMNEAL
- Local brand name: EXENATIDE SYNTHETIC
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
Byetta 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 Byetta approved in United States?
Yes. FDA authorised it on 28 April 2005; FDA authorised it on 21 December 2022; FDA authorised it on 19 November 2024.
Who is the marketing authorisation holder for Byetta in United States?
ASTRAZENECA AB holds the US marketing authorisation.