FDA Approval for ADLYXIN issued to SANOFI-AVENTIS US
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 208471
Company: SANOFI-AVENTIS US
Company: SANOFI-AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADLYXIN | LIXISENATIDE | 0.15MG/3ML (0.05MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
| ADLYXIN | LIXISENATIDE | 0.3MG/3ML (0.1MG/ML) | SOLUTION;SUBCUTANEOUS | Prescription | None | No | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 07/27/2016 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208471Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/208471Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2024 | SUPPL-9 | Supplement |
Label is not available on this site. |
||
| 09/28/2023 | SUPPL-7 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/208471Orig1s007ltr.pdf | |
| 06/10/2022 | SUPPL-5 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/208471Orig1s005ltr.pdf | |
| 07/30/2021 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208471s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208471Orig1s004ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/28/2023 | SUPPL-7 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208471s007lbl.pdf | |
| 06/10/2022 | SUPPL-5 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf | |
| 06/10/2022 | SUPPL-5 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/208471s005lbl.pdf | |
| 07/30/2021 | SUPPL-4 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208471s004lbl.pdf | |
| 07/27/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208471Orig1s000lbl.pdf |