FDA — authorised 28 April 2005
- Application: NDA021773
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: BYETTA
- Indication: INJECTABLE — SUBCUTANEOUS
- Status: approved
🇺🇸 Exenatide 2 MG in United States
FDA authorised Exenatide 2 MG on 28 April 2005
Marketing authorisations
FDA — authorised 27 January 2012
- Application: NDA022200
- Marketing authorisation holder: ASTRAZENECA AB
- Local brand name: BYDUREON
- Indication: FOR SUSPENSION, EXTENDED RELEASE — SUBCUTANEOUS
- Status: approved
FDA
- Status: approved
Exenatide 2 MG 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 Exenatide 2 MG approved in United States?
Yes. FDA authorised it on 28 April 2005; FDA authorised it on 27 January 2012; FDA has authorised it.
Who is the marketing authorisation holder for Exenatide 2 MG in United States?
ASTRAZENECA AB holds the US marketing authorisation.