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FDA BLA · BLA761425

USTEKINUMAB-TTWE

Sponsor: SAMSUNG BIOEPIS CO LTD

APPLICATION
BLA761425
TYPE
BLA
ORIGINAL APPROVAL
2024-06-28
LATEST ACTION
2025-11-18
ROUTE
INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

PYZCHIVAPrescription
USTEKINUMAB-TTWE 130MG/26ML(5MG/ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2025-11-18Labeling · Supplement 5 · standard — Letter ↗AP
2025-04-30Type 3 - New Dosage Form · Original · standard — Letter ↗AP
2025-03-13Labeling · Supplement 3 · standard — Label ↗AP
2024-12-20Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2024-12-20Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2024-06-28Type 3 - New Dosage Form · Original · standard — Letter ↗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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