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Bydureon

Bydureon is a brand of exenatide from AstraZeneca, first approved by the FDA on 2012-01-27 under applications NDA022200, NDA209210, authorised in the EU as Bydureon, with no open FDA supply records.

Bydureon is AstraZeneca's brand of exenatide, covering 2 FDA applications. The same molecule is also sold as Byetta — a separate application with its own approved uses and its own supply record, which is why the two are tracked apart here rather than merged. Nothing under this name is currently on the FDA shortage list. It is also authorised in the EU, which does not always follow the US indication wording.

Bydureon and Byetta are the same molecule. They are marketed under separate FDA applications with different approved indications, so they are distinct products on the regulatory record even though the active ingredient is identical. Compare the applications below. Side by side: Bydureon vs Byetta.

Active ingredient

exenatide

Sponsor

AstraZeneca

FDA applications

NDA022200, NDA209210

First FDA action

2012-01-27

Most recent FDA action

2025-05-28

FDA actions on file

80

EU authorisation

Bydureon

Active trials of exenatide

5

FDA record

Every approved submission filed under this brand, newest first, from Drugs@FDA: original approval, efficacy supplements, labeling changes and manufacturing updates. New safety language usually arrives in a labeling supplement.

For the molecule behind this brand — every trial, every indication under study and the full research record — see exenatide.