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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125319
Company: NOVARTIS PHARMS

Medication Guide

Summary Review

Products on BLA 125319

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ILARIS	CANAKINUMAB	180MG	INJECTABLE; SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125319

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2009	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/125319s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/125319s000_SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2023	SUPPL-107	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125319Orig1s107ltr.pdf
09/18/2020	SUPPL-100	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125319Orig1s100ltr.pdf
06/16/2020	SUPPL-97	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125319Orig1s097ltr.pdf
12/22/2016	SUPPL-88	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s088ltr.pdf
09/23/2016	SUPPL-87	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm
09/23/2016	SUPPL-86	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm
09/23/2016	SUPPL-85	Supplement	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s085,s086,s087ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125319Orig1s085,086,087TOC.cfm
07/21/2016	SUPPL-84	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125319Orig1s084ltr.pdf
10/16/2014	SUPPL-81	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125319s081lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125319Orig1s081ltr.pdf
05/09/2013	SUPPL-62	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125319s062lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125319Orig1s062ltr_repl.pdf
10/11/2012	SUPPL-54	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s0054.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319Orig1s054ltr.pdf
03/30/2012	SUPPL-47	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125319s047ltr.pdf
11/17/2011	SUPPL-14	Supplement		Label is not available on this site.

Labels for BLA 125319

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/25/2023	SUPPL-107	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125319s107lbl.pdf
09/18/2020	SUPPL-100	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s100lbl.pdf
06/16/2020	SUPPL-97	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125319s097lbl.pdf
12/22/2016	SUPPL-88	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s088lbl.pdf
09/23/2016	SUPPL-87	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf
09/23/2016	SUPPL-86	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf
09/23/2016	SUPPL-85	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/BLA125319_858687lbl.pdf
07/21/2016	SUPPL-84	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125319s084lbl.pdf
10/16/2014	SUPPL-81	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125319s081lbl.pdf
05/09/2013	SUPPL-62	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125319s062lbl.pdf
10/11/2012	SUPPL-54	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s0054.pdf
03/30/2012	SUPPL-47	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125319s047lbl.pdf
06/17/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/125319s000lbl.pdf

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