FDA Approval for KEVZARA issued to SANOFI SYNTHELABO
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761037
Company: SANOFI SYNTHELABO
Company: SANOFI SYNTHELABO
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| KEVZARA | SARILUMAB | 150MG/1.14ML | INJECTABLE;INJECTION | Prescription | None | TBD | No |
| KEVZARA | SARILUMAB | 200MG/1.14ML | INJECTABLE;INJECTION | Prescription | None | TBD | 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 |
|---|---|---|---|---|---|---|---|
| 05/22/2017 | ORIG-1 | Approval | N/A |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/761037Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/761037Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/10/2024 | SUPPL-15 | Supplement |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761037Orig1s015ltr.pdf |
| 02/28/2023 | SUPPL-13 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761037Orig1s013ltr.pdf | |
| 04/13/2018 | SUPPL-1 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/761037Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 02/28/2023 | SUPPL-13 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761037s013lbl.pdf | |
| 04/13/2018 | SUPPL-1 | Efficacy-Manufacturing Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761037s001lbl.pdf | |
| 05/22/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761037s000lbl.pdf |