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 authorised Exenatide Microspheres for Injection on 27 January 2012
Yes. FDA authorised it on 27 January 2012.
ASTRAZENECA AB holds the US marketing authorisation.