Source facts
FDA issued an approval letter for COSENTYX on 2026-04-20. The source metadata identifies BLA 761349, BLA 125504 as a supplement. Review the exact FDA letter for the approved conditions and labeling.
US FDA source recordAL · Approval Letter
COSENTYX — FDA Approval Letter (BLA 761349)
Issued to NOVARTIS PHARMS CORP. Application is approved as submitted.
Issued
April 20, 2026Application
BLA • 761349
Product
COSENTYX
Company
NOVARTIS PHARMS CORP
Stage
Final Decision
Assyro regulatory brief
FreeWhat did FDA decide for COSENTYX?
Source facts and Assyro context are separated so you can scan the action quickly without treating analysis as an FDA conclusion.
Key details in this letter
- 1FDA action: approval.
- 2Applications: BLA 761349, BLA 125504.
- 3Submission: supplement.
- 4Sponsor: NOVARTIS PHARMS CORP.
Suggested next step
Review the exact FDA letter for approved conditions, labeling, and postmarketing requirements.
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Common questions about the COSENTYX approval letter
Is COSENTYX FDA approved?
This letter documents an FDA approval action: FDA approved BLA 761349 for COSENTYX, sponsored by NOVARTIS PHARMS CORP, on April 20, 2026. Product may be marketed. Verify current status and labeling in the source letter, since later FDA actions can change them.
What is BLA 761349?
BLA 761349 is the application under which FDA issued this approval letter for COSENTYX to NOVARTIS PHARMS CORP. The letter is dated April 20, 2026.
What happens after an FDA approval letter?
The sponsor may market the product in line with the approved labeling. Approval letters typically set post-approval obligations: submitting final content of labeling, meeting any postmarketing requirements or commitments listed in the letter, updating Orange Book patent information within 30 days for NDAs, and ongoing annual reporting under 21 CFR 314.81.