← FDA DRUG APPROVALS

FDA BLA · BLA761419

STARJEMZA

ustekinumab-hmny

Sponsor: BIO-THERA SOLUTIONS LTD

APPLICATION
BLA761419
TYPE
BLA
ORIGINAL APPROVAL
2025-05-22
LATEST ACTION
2025-05-22
ROUTE
SUBCUTANEOUS, INTRAVENOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

STARJEMZAPrescription
USTEKINUMAB-HMNY 130MG/26ML · INJECTABLE · SUBCUTANEOUS
STARJEMZAPrescription
USTEKINUMAB-HMNY 90MG/ML · INJECTABLE · SUBCUTANEOUS
STARJEMZAPrescription
USTEKINUMAB-HMNY 45MG/0.5ML · INJECTABLE · SUBCUTANEOUS

Approval history

2025-05-22Type 2 - New Active Ingredient · 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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