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FDA BLA · BLA761279

OMVOH

mirikizumab-mrkz

Sponsor: ELI LILLY AND CO

APPLICATION
BLA761279
TYPE
BLA
ORIGINAL APPROVAL
2023-10-26
LATEST ACTION
2025-10-23
ROUTE
INTRAVENOUS, SUBCUTANEOUS, SINGLE-USE
DOSAGE FORM
INJECTABLE, VIAL
MARKETING STATUS
Prescription

Products

OMVOHPrescription
MIRIKIZUMAB-MRKZ 100MG/ML · INJECTABLE · SUBCUTANEOUS
OMVOHPrescription
MIRIKIZUMAB-MRKZ 300MG/15ML · VIAL · SINGLE-USE

Approval history

2025-10-23Labeling · Supplement 5 · standard — Label ↗AP
2025-01-15Efficacy · Supplement 2 · standard — Label ↗AP
2025-01-15Efficacy · Supplement 3 · standard — Label ↗AP
2024-04-29Labeling · Supplement 1 · standard — Letter ↗AP
2023-10-26Type 1 - New Molecular Entity · 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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