← FDA DRUG APPROVALS

FDA NDA · NDA022200

BYDUREON PEN

Sponsor: ASTRAZENECA AB

APPLICATION
NDA022200
TYPE
NDA
ORIGINAL APPROVAL
2012-01-27
LATEST ACTION
2025-05-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
FOR SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

BYDUREON PEN · ReferenceDiscontinued
EXENATIDE SYNTHETIC 2MG · FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS
BYDUREON · ReferenceDiscontinued
EXENATIDE SYNTHETIC 2MG/VIAL · FOR SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS

Approval history

2025-05-28Labeling · Supplement 36 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 35 · 901 required — Label ↗AP
2022-12-21Labeling · Supplement 34 · standard — Letter ↗AP
2022-07-26Labeling · Supplement 32 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 33 · 901 required — Letter ↗AP
2021-07-22Efficacy · Supplement 31 · priority — Label ↗AP
2020-02-28Labeling · Supplement 30 · standard — Label ↗AP
2019-02-15Efficacy · Supplement 28 · standard — Label ↗AP
2018-04-02Efficacy · Supplement 26 · standard — Label ↗AP
2017-10-20Efficacy · Supplement 25 · standard — Letter ↗AP
2016-06-10Manufacturing (CMC) · Supplement 24 · standardAP
2016-01-11Manufacturing (CMC) · Supplement 23 · standardAP
2015-12-31Manufacturing (CMC) · Supplement 21 · standardAP
2015-12-23Manufacturing (CMC) · Supplement 22 · standardAP
2015-09-24Efficacy · Supplement 18 · standard — Letter ↗AP
2015-09-24Efficacy · Supplement 16 · standard — Label ↗AP
2015-09-24Efficacy · Supplement 17 · standard — Label ↗AP
2015-09-24Efficacy · Supplement 15 · standard — Label ↗AP
2015-09-18Labeling · Supplement 20 · standard — Label ↗AP
2015-08-14Manufacturing (CMC) · Supplement 11 · standardAP
2015-04-29REMS · Supplement 10 — Letter ↗AP
2015-03-09Labeling · Supplement 19 · 901 required — Letter ↗AP
2015-03-05Manufacturing (CMC) · Supplement 14 · standard — Label ↗AP
2014-05-22Labeling · Supplement 13 · standard — Label ↗AP
2014-05-22Labeling · Supplement 12 · 901 required — Letter ↗AP
2014-03-24Manufacturing (CMC) · Supplement 9 · standardAP
2014-02-28Labeling · Supplement 7 · standardAP
2014-02-28Labeling · Supplement 8 · standard — Review ↗AP
2013-06-12Manufacturing (CMC) · Supplement 4 · standardAP
2013-02-27Manufacturing (CMC) · Supplement 5 · standardAP
2012-01-27Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →