Bydureon, Bydureon Pen

NDA 22200, held by Astrazeneca AB. Exenatide Synthetic.

As of Nov 13, 2026, NDA 22200 (Bydureon, Bydureon Pen), held by Astrazeneca AB, was first approved by FDA on Jan 27, 2012, with 30 approved supplements and 0 published complete response letters.

First approved: Jan 27, 2012
Review: Standard
Supplements approved: 30
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 31 submissions below


Jul 22, 2021	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 15, 2019	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 2, 2018	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 20, 2017	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 27, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Bydureon2MG/VIAL · for suspension, extended release;subcutaneous	Exenatide Synthetic	DiscontinuedReference drug
Bydureon Pen2MG · for suspension, extended release;subcutaneous	Exenatide Synthetic	DiscontinuedReference drug

All 31 submissions, including labeling and manufacturing supplements


May 28, 2025	Supplement 36Labeling · Standard review	Approved	Label Medication Guide Letter
Nov 1, 2024	Supplement 35Labeling	Approved	Letter Label
Dec 21, 2022	Supplement 34Labeling · Standard review	Approved	Label Letter
Jul 26, 2022	Supplement 32Labeling · Standard review	Approved	Letter Label
Jun 10, 2022	Supplement 33Labeling	Approved	Label Letter
Jul 22, 2021	Supplement 31Efficacy (new indication or use) · Priority review	Approved	Letter Label
Feb 28, 2020	Supplement 30Labeling · Standard review	Approved	Letter Label
Feb 15, 2019	Supplement 28Efficacy (new indication or use) · Standard review	Approved	Letter Label
Apr 2, 2018	Supplement 26Efficacy (new indication or use) · Standard review	Approved	Label Letter
Oct 20, 2017	Supplement 25Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jun 10, 2016	Supplement 24Manufacturing · Standard review	Approved	None posted
Jan 11, 2016	Supplement 23Manufacturing · Standard review	Approved	None posted
Dec 31, 2015	Supplement 21Manufacturing · Standard review	Approved	None posted
Dec 23, 2015	Supplement 22Manufacturing · Standard review	Approved	None posted
Sep 24, 2015	Supplement 18Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 17Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 16Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 24, 2015	Supplement 15Efficacy (new indication or use) · Standard review	Approved	Label Letter
Sep 18, 2015	Supplement 20Labeling · Standard review	Approved	Label Letter
Aug 14, 2015	Supplement 11Manufacturing · Standard review	Approved	None posted
Apr 29, 2015	Supplement 10REMS	Approved	Letter
Mar 9, 2015	Supplement 19Labeling	Approved	Label Letter
Mar 5, 2015	Supplement 14Manufacturing · Standard review	Approved	Label Letter
May 22, 2014	Supplement 13Labeling · Standard review	Approved	Label Letter
May 22, 2014	Supplement 12Labeling	Approved	Label Letter
Mar 24, 2014	Supplement 9Manufacturing · Standard review	Approved	None posted
Feb 28, 2014	Supplement 8Labeling · Standard review	Approved	Review Letter Label
Feb 28, 2014	Supplement 7Labeling · Standard review	Approved	None posted
Jun 12, 2013	Supplement 4Manufacturing · Standard review	Approved	None posted
Feb 27, 2013	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 27, 2012	Original applicationNew dosage form · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 22200
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