← FDA DRUG APPROVALS

FDA BLA · BLA761498

AVTOZMA

tocilizumab

Sponsor: CELLTRION INC

APPLICATION
BLA761498
TYPE
BLA
ORIGINAL APPROVAL
2026-01-21
LATEST ACTION
2026-01-21
ROUTE
SUBCUTANEOUS, IV (INFUSION)
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

AVTOZMAPrescription
TOCILIZUMAB-ANOH 400MG/20ML(20MG/ML) · INJECTABLE · IV (INFUSION)
AVTOZMAPrescription
TOCILIZUMAB-ANOH 80MG/4ML(20MG/ML) · INJECTABLE · IV (INFUSION)
AVTOZMAPrescription
TOCILIZUMAB-ANOH 162MG/20ML(20MG/ML) · INJECTABLE · SUBCUTANEOUS
AVTOZMAPrescription
TOCILIZUMAB-ANOH 200MG/10ML(20MG/ML) · INJECTABLE · IV (INFUSION)

Approval history

2026-01-21UNKNOWN · Original · standardLabelAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industryGMP disciplineFDA drug shortagesFDA 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 →