← FDA DRUG APPROVALS

FDA BLA · BLA761338

STEQEYMA

ustekinumab-stba

Sponsor: CELLTRION, INC.

APPLICATION
BLA761338
TYPE
BLA
ORIGINAL APPROVAL
2024-12-17
LATEST ACTION
2025-12-12
ROUTE
SUBCUTANEOUS, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

STEQEYMAPrescription
USTEKINUMAB-STBA 90MG/ML · INJECTABLE · SUBCUTANEOUS
STEQEYMAPrescription
USTEKINUMAB-STBA 130MG/26ML · INJECTABLE · INTRAVENOUS
STEQEYMAPrescription
USTEKINUMAB-STBA 45MG/0.5ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-12-12Labeling · Supplement 7 · standard — Letter ↗AP
2025-06-13Labeling · Supplement 3 · standard — Letter ↗AP
2025-04-30Type 2 - New Active Ingredient · Original · standard — Letter ↗AP
2025-04-28Labeling · Supplement 1 · standard — Label ↗AP
2024-12-17Type 2 - New Active Ingredient · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →