FDA BLA · BLA761349

COSENTYX

secukinumab

Sponsor: NOVARTIS PHARMS CORP

What this page does not claim

A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.

APPLICATION
BLA761349
TYPE
BLA
ORIGINAL APPROVAL
2023-10-06
LATEST ACTION
2026-10-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

COSENTYXPrescription
SECUKINUMAB 150MG · INJECTABLE · INJECTION

Approval history

2026-10-15Efficacy · Supplement 13 · standard — Letter ↗AP
2026-04-17Labeling · Supplement 11 · standard — Letter ↗AP
2026-04-17Labeling · Supplement 12 · standard — Letter ↗AP
2026-03-12Labeling · Supplement 10 · standard — Letter ↗AP
2025-08-06Labeling · Supplement 8 · standard — Letter ↗AP
2025-03-12Labeling · Supplement 7 · standard — Letter ↗AP
2024-10-04Labeling · Supplement 5 · standard — Label ↗AP
2024-08-16Labeling · Supplement 6 · standard — Letter ↗AP
2024-04-04Labeling · Supplement 1 · standardAP
2023-11-21Labeling · Supplement 4 · standard — Letter ↗AP
2023-10-06Type 3 - New Dosage Form · Original · standard — Letter ↗AP