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FDA BLA · BLA761390

NEMLUVIO

nemolizumab-ilto

Sponsor: GALDERMA LABS LP

APPLICATION
BLA761390
TYPE
BLA
ORIGINAL APPROVAL
2024-08-12
LATEST ACTION
2025-06-26
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NEMLUVIOPrescription
NEMOLIZUMAB-ILTO 30MG · INJECTABLE · INJECTION

Approval history

2025-06-26Labeling · Supplement 2 · standardLetterAP
2025-04-21Labeling · Supplement 1 · standardLetterAP
2024-08-12Type 1 - New Molecular Entity · Original · priorityLabelAP
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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