NDA 209210, held by Astrazeneca AB. Exenatide Synthetic.
As of Nov 14, 2026, NDA 209210 (Bydureon Bcise), held by Astrazeneca AB, was first approved by FDA on Oct 20, 2017, with 17 approved supplements and 0 published complete response letters.
| Jul 22, 2021 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Jul 25, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Feb 15, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2017 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Bydureon Bcise2MG/0.85ML (2MG/0.85ML) · suspension, extended release;subcutaneous | Exenatide Synthetic | DiscontinuedReference drug |
| May 28, 2025 | Supplement 25Labeling · Standard review | Approved | |
| Nov 1, 2024 | Supplement 24Labeling | Approved | |
| Mar 6, 2024 | Supplement 23Labeling · Standard review | Approved | |
| Dec 21, 2022 | Supplement 22Labeling · Standard review | Approved | |
| Jul 26, 2022 | Supplement 19Labeling · Standard review | Approved | |
| Jun 10, 2022 | Supplement 21Labeling | Approved | |
| Jul 22, 2021 | Supplement 17Efficacy (new indication or use) · Priority review | Approved | |
| Dec 2, 2020 | Supplement 14Labeling · Standard review | Approved | |
| Feb 28, 2020 | Supplement 11Labeling · Standard review | Approved | |
| Jul 25, 2019 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jul 25, 2019 | Supplement 8Labeling · Standard review | Approved | |
| Feb 15, 2019 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Oct 20, 2017 | Original applicationNew dosage form · Standard review | Approved |
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
