Byetta

For type 2 diabetes mellitus. NDA 21773, held by Astrazeneca AB. Exenatide Synthetic.

As of Nov 14, 2026, NDA 21773 (Byetta), held by Astrazeneca AB, was first approved by FDA on Apr 28, 2005, with 35 approved supplements and 0 published complete response letters.

First approved: Apr 28, 2005
Review: Standard
Supplements approved: 35
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

BYETTA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use

BYETTA contains exenatide. Coadministration with other exenatide-containing products is not recommended.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 36 submissions below


Nov 4, 2021	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Label Letter
Nov 24, 2014	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Oct 19, 2011	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 19, 2011	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Dec 22, 2006	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Apr 28, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Products

2 strengths and forms


Byetta300MCG/1.2ML (250MCG/ML) · injectable;subcutaneous	Exenatide Synthetic	DiscontinuedReference drug
Byetta600MCG/2.4ML (250MCG/ML) · injectable;subcutaneous	Exenatide Synthetic	DiscontinuedReference drug

All 36 submissions, including labeling and manufacturing supplements


Sep 2, 2025	Supplement 51Labeling · Standard review	Approved	Label Letter
May 28, 2025	Supplement 50Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 1, 2024	Supplement 49Labeling	Approved	Letter Label
Dec 21, 2022	Supplement 48Labeling · Standard review	Approved	Label Letter
Jun 10, 2022	Supplement 47Labeling	Approved	Label Letter
Jun 10, 2022	Supplement 46Labeling · Standard review	Approved	Label Letter
Nov 4, 2021	Supplement 45Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 17, 2021	Supplement 44Labeling · Standard review	Approved	Letter Label
Feb 28, 2020	Supplement 43Labeling · Standard review	Approved	Letter Label
Dec 20, 2018	Supplement 41Labeling · Standard review	Approved	Label
Feb 25, 2015	Supplement 40Labeling	Approved	Label Letter
Nov 24, 2014	Supplement 36Efficacy (new indication or use) · Standard review	Approved	Letter Label
Aug 12, 2014	Supplement 39Manufacturing · Standard review	Approved	None posted
Jun 4, 2014	Supplement 38Manufacturing · Standard review	Approved	None posted
Jun 4, 2014	Supplement 37Manufacturing · Standard review	Approved	None posted
Apr 23, 2014	Supplement 35Manufacturing · Standard review	Approved	None posted
Jan 30, 2014	Supplement 34Manufacturing · Standard review	Approved	None posted
Oct 19, 2011	Supplement 30Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 19, 2011	Supplement 29Efficacy (new indication or use) · Standard review	Approved	Label Letter
Aug 5, 2011	Supplement 31REMS	Approved	Letter
Nov 12, 2010	Supplement 28Labeling	Approved	Letter Label
Aug 13, 2010	Supplement 26Labeling	Approved	Letter
Oct 30, 2009	Supplement 25REMS	Approved	Letter Label
Oct 30, 2009	Supplement 22Labeling · Standard review	Approved	Letter Label
Oct 30, 2009	Supplement 18Labeling · Standard review	Approved	Letter Label
Oct 30, 2009	Supplement 17Labeling · Standard review	Approved	Letter Label
Oct 30, 2009	Supplement 11Labeling · Standard review	Approved	Letter Label
Oct 30, 2009	Supplement 9Labeling · Standard review	Approved	Letter Label
Jun 17, 2008	Supplement 10Labeling · Standard review	Approved	Letter Label
Jan 11, 2008	Supplement 12Labeling · Standard review	Approved	Letter Label
Feb 10, 2007	Supplement 7Manufacturing	Approved	Letter Label
Dec 22, 2006	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 22, 2006	Supplement 2Efficacy (new indication or use)	Approved	Letter Label
Nov 1, 2006	Supplement 5Labeling · Standard review	Approved	Label Letter
Oct 12, 2006	Supplement 4Labeling · Standard review	Approved	Letter Label
Apr 28, 2005	Original applicationNew molecular entity · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21773
Drugs@FDA: Overview at FDA
Company: AstraZeneca Pharmaceuticals LP

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters