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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761113
Company: SANOFI AVENTIS US

Products on BLA 761113

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761113

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
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

Labels for BLA 761113

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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

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