Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761349s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761349Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
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
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