Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761037
Company: SANOFI SYNTHELABO

• Medication Guide

Products on BLA 761037

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761037

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
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

Labels for BLA 761037

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