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FDA BLA · BLA761061

TREMFYA

guselkumab

Sponsor: JANSSEN BIOTECH

APPLICATION
BLA761061
TYPE
BLA
ORIGINAL APPROVAL
2017-07-13
LATEST ACTION
2026-05-28
ROUTE
SUBCUTANEOUS, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

TREMFYAPrescription
GUSELKUMAB 100MG/ML · INJECTABLE · INJECTION

Approval history

2026-05-28Efficacy · Supplement 34 · standard — Letter ↗AP
2025-09-26Efficacy · Supplement 29 · standard — Label ↗AP
2025-09-26Efficacy · Supplement 28 · standard — Label ↗AP
2025-09-19Efficacy · Supplement 26 · standard — Label ↗AP
2025-06-17Labeling · Supplement 30 · standard — Letter ↗AP
2025-03-25Manufacturing (CMC) · Supplement 27 · standard — Label ↗AP
2025-03-20Efficacy · Supplement 24 · priority — Label ↗AP
2024-09-11Efficacy · Supplement 21 · priority — Label ↗AP
2023-06-29Labeling · Supplement 15 · standard — Letter ↗AP
2020-07-13Efficacy · Supplement 7 · standard — Label ↗AP
2020-06-01Labeling · Supplement 9 · standard — Label ↗AP
2019-11-22Efficacy · Supplement 4 · standard — Letter ↗AP
2019-04-04Labeling · Supplement 2 · standard — Letter ↗AP
2019-01-29Efficacy · Supplement 1 · standard — Letter ↗AP
2017-07-13Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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