FDA Approval for SARCLISA issued to SANOFI AVENTIS US
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Biotechnology: Pharmaceutical Preparations
Health Care
Biologic License Application (BLA): 761113
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SARCLISA | ISATUXIMAB-IRFC | 100MG/5ML (20MG/ML) | INJECTABLE;INJECTION | Prescription | None | No | No |
| SARCLISA | ISATUXIMAB-IRFC | 500MG/25ML (20MG/ML) | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 03/02/2020 | ORIG-1 | Approval | N/A; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/761113Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2020/761113Orig1s000TOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/20/2024 | SUPPL-14 | Supplement |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf | |
| 11/01/2023 | SUPPL-9 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761113s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761113Orig1s009ltr.pdf | |
| 07/15/2022 | SUPPL-6 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761113s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761113Orig1s006ltr.pdf | |
| 03/18/2021 | SUPPL-4 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761113Orig1s004ltr.pdf | |
| 03/31/2021 | SUPPL-3 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761113Orig1s003ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/20/2024 | SUPPL-14 | Efficacy | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf | |
| 11/01/2023 | SUPPL-9 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761113s009lbl.pdf | |
| 07/15/2022 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761113s006lbl.pdf | |
| 03/31/2021 | SUPPL-3 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s003lbl.pdf | |
| 03/18/2021 | SUPPL-4 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf | |
| 03/18/2021 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf | |
| 03/02/2020 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf |