← FDA DRUG APPROVALS

FDA BLA · BLA125261

USTEKINUMAB

Sponsor: CENTOCOR ORTHO BIOTECH INC

APPLICATION
BLA125261
TYPE
BLA
ORIGINAL APPROVAL
2009-09-25
LATEST ACTION
2026-07-15
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

STELARAPrescription
USTEKINUMAB 45MG/0.5ML · INJECTABLE · INJECTION
STELARAPrescription
USTEKINUMAB 90MG/1ML · INJECTABLE · INJECTION

Approval history

2026-07-15Labeling · Supplement 174 · standard — Letter ↗AP
2026-04-15Labeling · Supplement 172 · standard — Letter ↗AP
2025-11-03Labeling · Supplement 171 · standard — Label ↗AP
2025-06-27Labeling · Supplement 167 · standard — Letter ↗AP
2025-04-01Labeling · Supplement 168 · standard — Label ↗AP
2024-11-15Labeling · Supplement 166 · standard — Label ↗AP
2024-03-18Labeling · Supplement 163 · standard — Letter ↗AP
2023-03-06Labeling · Supplement 158 · standard — Letter ↗AP
2022-07-29Efficacy · Supplement 161 · standard — Letter ↗AP
2020-12-11Labeling · Supplement 157 · standard — Letter ↗AP
2020-12-01Labeling · Supplement 154 · standard — Label ↗AP
2020-07-29Efficacy · Supplement 150 · standard — Label ↗AP
2020-04-06Labeling · Supplement 153 · standard — Label ↗AP
2019-11-07Labeling · Supplement 142 · standard — Letter ↗AP
2019-10-18Labeling · Supplement 152 · standard — Letter ↗AP
2018-06-08Labeling · Supplement 147 · 901 required — Label ↗AP
2018-02-16Labeling · Supplement 141 · standard — Label ↗AP
2017-10-13Efficacy · Supplement 138 · standard — Letter ↗AP
2017-02-15UNKNOWN · Supplement 129 · standard — Letter ↗AP
2014-03-04Labeling · Supplement 114 · standard — Label ↗AP
2013-09-20Efficacy · Supplement 103 · standard — Label ↗AP
2013-05-21Efficacy · Supplement 86 · standard — Label ↗AP
2013-04-29Labeling · Supplement 99 · standard — Letter ↗AP
2013-01-25Labeling · Supplement 91 · standard — Label ↗AP
2012-06-14Labeling · Supplement 59 · standard — Label ↗AP
2012-05-31Efficacy · Supplement 49 · standard — Label ↗AP
2012-05-02Labeling · Supplement 63 · standard — Letter ↗AP
2012-04-06Labeling · Supplement 58 · standard — Letter ↗AP
2010-10-20Labeling · Supplement 13 · standard — Label ↗AP
2009-12-30Efficacy · Supplement 1 · standard — Label ↗AP
2009-09-25Type 1 - New Molecular Entity · 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 →