BYDUREON (AstraZeneca Pty Ltd)
Product name
BYDUREON
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
183 working days (255)
Active ingredients
exenatide
Registration type
EOI
Indication
BYDUREON (once weekly injection) is now also indicated for use in combination with dapagliflozin as add on therapy to metformin in patients with type 2 diabetes mellitus who have not achieved adequate glycaemic control on metformin alone.