← FDA DRUG APPROVALS

FDA BLA · BLA761044

USTEKINUMAB

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761044
TYPE
BLA
ORIGINAL APPROVAL
2016-09-23
LATEST ACTION
2026-04-15
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

STELARAPrescription
USTEKINUMAB 130MG/26ML · INJECTABLE · INJECTION

Approval history

2026-04-15Efficacy · Supplement 20 · standard — Letter ↗AP
2025-11-03Labeling · Supplement 19 · standard — Label ↗AP
2025-06-27Labeling · Supplement 15 · standard — Letter ↗AP
2025-04-01Labeling · Supplement 16 · standard — Label ↗AP
2024-11-15Labeling · Supplement 14 · standard — Letter ↗AP
2024-03-18Labeling · Supplement 13 · standard — Letter ↗AP
2023-03-06Labeling · Supplement 9 · standard — Letter ↗AP
2022-07-29Labeling · Supplement 10 · standard — Letter ↗AP
2020-12-11Labeling · Supplement 8 · standard — Label ↗AP
2020-12-01Labeling · Supplement 6 · standard — Label ↗AP
2020-04-07Labeling · Supplement 5 · standard — Label ↗AP
2019-11-07Labeling · Supplement 1 · standard — Letter ↗AP
2019-10-18Efficacy · Supplement 3 · standard — Letter ↗AP
2016-09-23Type 3 - New Dosage Form · 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 →