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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125496
Company: EUSA PHARMA LIMITED

Summary Review

Products on BLA 125496

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SYLVANT	SILTUXIMAB	100MG	INJECTABLE;INJECTION	Prescription	None	No	No
SYLVANT	SILTUXIMAB	400MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125496

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2014	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125496s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/125496Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2019	SUPPL-18	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125496Orig1s018ltr.pdf
05/31/2018	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125496s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125496Orig1s013ltr.pdf
03/24/2017	SUPPL-5	Supplement		Label is not available on this site.

Labels for BLA 125496

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/05/2019	SUPPL-18	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf
12/05/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125496s018lbl.pdf
05/31/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125496s013lbl.pdf
04/23/2014	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125496s000lbl.pdf

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