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FDA BLA · BLA761306

EBGLYSS

lebrikizumab-lbkz

Sponsor: ELI LILLY AND CO

APPLICATION
BLA761306
TYPE
BLA
ORIGINAL APPROVAL
2024-09-13
LATEST ACTION
2026-06-09
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

EBGLYSSPrescription
LEBRIKIZUMAB-LBKZ 250MG/2ML · INJECTABLE · INJECTION

Approval history

2026-06-09Efficacy · Supplement 6 · standard — Letter ↗AP
2025-10-28Labeling · Supplement 5 · standard — Label ↗AP
2025-05-22Labeling · Supplement 3 · standard — Letter ↗AP
2024-09-13Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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