← FDA DRUG APPROVALS

FDA BLA · BLA125276

ACTEMRA

tocilizumab

Sponsor: GENENTECH

APPLICATION
BLA125276
TYPE
BLA
ORIGINAL APPROVAL
2010-01-08
LATEST ACTION
2025-12-10
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ACTEMRAPrescription
TOCILIZUMAB 400MG/20ML · INJECTABLE · INJECTION
ACTEMRAPrescription
TOCILIZUMAB 80MG/4ML · INJECTABLE · INJECTION
ACTEMRAPrescription
TOCILIZUMAB 200MG/10ML · INJECTABLE · INJECTION

Approval history

2025-12-10Labeling · Supplement 147 · standard — Letter ↗AP
2025-08-08Efficacy · Supplement 149 · standard — Label ↗AP
2024-12-10Labeling · Supplement 146 · standard — Letter ↗AP
2024-09-20Efficacy · Supplement 144 · standard — Label ↗AP
2024-09-19Labeling · Supplement 148 · standard — Letter ↗AP
2022-12-21Efficacy · Supplement 138 · priority — Label ↗AP
2022-02-28Efficacy · Supplement 134 · standard — Letter ↗AP
2021-10-22Labeling · Supplement 135 · standard — Letter ↗AP
2021-03-04Labeling · Supplement 131 · standard — Letter ↗AP
2020-05-28Labeling · Supplement 129 · standard — Label ↗AP
2019-06-11Labeling · Supplement 127 · 901 required — Letter ↗AP
2019-04-11Efficacy · Supplement 121 · standard — Label ↗AP
2019-04-11Efficacy · Supplement 120 · standard — Label ↗AP
2018-12-20Labeling · Supplement 125 · standard — Label ↗AP
2018-11-19Labeling · Supplement 118 · standard — Label ↗AP
2018-09-12Labeling · Supplement 122 · standard — Label ↗AP
2018-05-17Labeling · Supplement 117 · standard — Label ↗AP
2018-05-11Efficacy · Supplement 115 · priority — Label ↗AP
2018-03-22Labeling · Supplement 116 · standard — Label ↗AP
2017-08-30Efficacy · Supplement 114 · priority — Label ↗AP
2017-05-22Labeling · Supplement 112 · standard — Label ↗AP
2017-03-30Labeling · Supplement 111 · standard — Label ↗AP
2016-09-23Efficacy · Supplement 107 · standard — Label ↗AP
2015-08-18REMS · Supplement 106 — Letter ↗AP
2014-11-13Labeling · Supplement 105 · standard — Letter ↗AP
2013-10-21Labeling · Supplement 92 · standard — Label ↗AP
2013-07-02Labeling · Supplement 75 · standard — Letter ↗AP
2013-04-29Efficacy · Supplement 64 · standard — Review ↗AP
2012-10-11Efficacy · Supplement 49 · standard — Label ↗AP
2012-08-13Labeling · Supplement 46 · standard — Label ↗AP
2012-06-20Labeling · Supplement 48 · standard — Letter ↗AP
2011-04-15Labeling · Supplement 23 · standard — Label ↗AP
2011-04-15Efficacy · Supplement 22 · priority — Label ↗AP
2011-01-04Efficacy · Supplement 7 · standard — Label ↗AP
2011-01-04Efficacy · Supplement 11 · standard — Label ↗AP
2011-01-04Efficacy · Supplement 10 · standard — Label ↗AP
2010-01-08Type 1 - New Molecular Entity · Original · standard — Pediatric Medical Review ↗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 →