← FDA DRUG APPROVALS

FDA NDA · NDA209210

BYDUREON BCISE

Sponsor: ASTRAZENECA AB

APPLICATION
NDA209210
TYPE
NDA
ORIGINAL APPROVAL
2017-10-20
LATEST ACTION
2025-05-28
ROUTE
SUBCUTANEOUS
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

BYDUREON BCISE · ReferenceDiscontinued
EXENATIDE SYNTHETIC 2MG/0.85ML (2MG/0.85ML) · SUSPENSION, EXTENDED RELEASE · SUBCUTANEOUS

Approval history

2025-05-28Labeling · Supplement 25 · standard — Letter ↗AP
2024-11-01Labeling · Supplement 24 · 901 required — Label ↗AP
2024-03-06Labeling · Supplement 23 · standard — Label ↗AP
2022-12-21Labeling · Supplement 22 · standard — Letter ↗AP
2022-07-26Labeling · Supplement 19 · standard — Letter ↗AP
2022-06-10Labeling · Supplement 21 · 901 required — Letter ↗AP
2021-07-22Efficacy · Supplement 17 · priority — Label ↗AP
2020-12-02Labeling · Supplement 14 · standard — Label ↗AP
2020-02-28Labeling · Supplement 11 · standard — Label ↗AP
2019-07-25Efficacy · Supplement 7 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 5 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 3 · standard — Letter ↗AP
2019-07-25Labeling · Supplement 8 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 6 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 4 · standard — Letter ↗AP
2019-07-25Efficacy · Supplement 2 · standard — Letter ↗AP
2019-02-15Efficacy · Supplement 1 · standard — Label ↗AP
2017-10-20Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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.

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