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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761349
Company: NOVARTIS PHARMS CORP

Medication Guide

Products on BLA 761349

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COSENTYX	SECUKINUMAB	150MG	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761349

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/06/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761349s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761349Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761349Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/12/2026	SUPPL-10	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/125504Orig1s091;761349Orig1s010ltr.pdf
08/06/2025	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125504Orig1s088,761349Orig1s008correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/125504Orig1s088, 761349Orig1s008correctedltr.pdf
03/12/2025	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761349Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761349Orig1s007ltr.pdf
08/16/2024	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761349s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761349Orig1s006ltr.pdf
10/04/2024	SUPPL-5	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125504Orig1s080, 761349Orig1s005lbl.pdf
11/21/2023	SUPPL-4	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
04/04/2024	SUPPL-1	Supplement		Label is not available on this site.

Labels for BLA 761349

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/06/2025	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/125504Orig1s088,761349Orig1s008correctedlbl.pdf
03/12/2025	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761349Orig1s007lbl.pdf
10/04/2024	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125504Orig1s080, 761349Orig1s005lbl.pdf
08/16/2024	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761349s006lbl.pdf
11/21/2023	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125504s066,761349s004lbl.pdf
10/06/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761349s000lbl.pdf

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