Pipeline › exenatide › Byetta

Byetta

Byetta is a brand of exenatide from AstraZeneca, first approved by the FDA on 2005-04-28 under applications NDA021773, NDA021919, authorised in the EU as Byetta, with no open FDA supply records.

Byetta is AstraZeneca's brand of exenatide, covering 2 FDA applications. The same molecule is also sold as Bydureon — 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. Its current FDA label, effective 2025-09-02, covers type 2 diabetes. 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.

Byetta and Bydureon 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: Byetta vs Bydureon.

Active ingredient

exenatide

Sponsor

AstraZeneca

FDA applications

NDA021773, NDA021919

First FDA action

2005-04-28

Most recent FDA action

2025-09-02

FDA actions on file

37

EU authorisation

Byetta

Active trials of exenatide

5

Approved indications

Quoted from the current FDA label for each application. This is what the drug is approved to treat in the US — separate from the conditions it is being studied in.

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.