Drugs@FDA: FDA-Approved Drugs
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)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761113Orig1s014ltr.pdf | |
10/25/2024 | SUPPL-12 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761113Orig1s012ltr.pdf | |
10/25/2024 | SUPPL-11 | Supplement |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761113Orig1s011ltr.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 |
---|---|---|---|---|---|
10/25/2024 | SUPPL-12 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s012lbl.pdf | |
10/25/2024 | SUPPL-11 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761113s011lbl.pdf | |
09/20/2024 | SUPPL-14 | Efficacy-New Indication | 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-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761113s004lbl.pdf | |
03/18/2021 | SUPPL-4 | Labeling-Patient 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 |