← FDA DRUG APPROVALS

FDA BLA · BLA761449

TYENNE

tocilizumab-aazg

Sponsor: FRESENIUS KABI USA

APPLICATION
BLA761449
TYPE
BLA
ORIGINAL APPROVAL
2025-03-14
LATEST ACTION
2026-05-20
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TYENNEPrescription
TOCILIZUMAB-AAZG 162MG/0.9ML · INJECTABLE · SUBCUTANEOUS

Approval history

2026-05-20Labeling · Supplement 6 · standard — Label ↗AP
2025-05-12Labeling · Supplement 1 · standard — Letter ↗AP
2025-03-14UNKNOWN · 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.

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