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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125504
Company: NOVARTIS PHARMS CORP

Medication Guide

Summary Review

Products on BLA 125504

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSENTYX	SECUKINUMAB	150MG/ML	INJECTABLE;INJECTION	Prescription	TBD	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125504

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/21/2015	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125504Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125504Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/06/2023	SUPPL-73	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s073lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s073ltr.pdf
07/24/2023	SUPPL-67	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s054;s055;s067ltr.pdf
11/21/2023	SUPPL-66	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s066,761349s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s066; 761349Orig1s004ltr.pdf
10/31/2023	SUPPL-63	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s063lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s063ltr.pdf
07/24/2023	SUPPL-55	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s054;s055;s067ltr.pdf
07/24/2023	SUPPL-54	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s054;s055;s067ltr.pdf
12/22/2021	SUPPL-51	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s050, s051ltr.pdf
12/22/2021	SUPPL-50	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s050, s051ltr.pdf
05/11/2023	SUPPL-44	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125504Orig1s044ltr.pdf
05/28/2021	SUPPL-43	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/125504Orig1s043ltr.pdf
06/16/2020	SUPPL-35	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125504Orig1s035ltr.pdf
01/29/2020	SUPPL-31	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125504Orig1s031ltr.pdf
09/15/2017	SUPPL-16	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125504Orig1s016ltr.pdf
01/23/2018	SUPPL-13	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s013ltr.pdf
06/19/2018	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125504Orig1s005ltr.pdf
01/15/2016	SUPPL-2	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125504Orig1s002.pdf
01/15/2016	SUPPL-1	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125504Orig1s001,s002ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/125504Orig1s001.pdf

Labels for BLA 125504

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/21/2023	SUPPL-66	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s066,761349s004lbl.pdf
10/31/2023	SUPPL-63	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s063lbl.pdf
10/06/2023	SUPPL-73	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s073lbl.pdf
07/24/2023	SUPPL-67	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf
07/24/2023	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf
07/24/2023	SUPPL-55	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf
07/24/2023	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504Orig1s054s055s067lbl.pdf
05/11/2023	SUPPL-44	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s044lbl.pdf
12/22/2021	SUPPL-51	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf
12/22/2021	SUPPL-50	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504_S050_S051lbl.pdf
05/28/2021	SUPPL-43	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/125504s043lbl.pdf
06/16/2020	SUPPL-35	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s035lbl.pdf
01/29/2020	SUPPL-31	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125504s031lbl.pdf
01/23/2018	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125504s013lbl.pdf
09/15/2017	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf
09/15/2017	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125504s016lbl.pdf
01/15/2016	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf
01/15/2016	SUPPL-1	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125504s001s002lbl.pdf
01/21/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125504s000lbl.pdf

Therapeutic Equivalents for BLA 125504

COSENTYX

There are no Therapeutic Equivalents.

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