Home Applications 761279 Application 761279
Type BLA
Sponsor ELI LILLY AND CO Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 761279 Omvoh mirikizumab-mrkz 351(a) Rx 2026-09-01
Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 OMVOH MIRIKIZUMAB-MRKZ VIAL; SINGLE-USE 300MG/15ML No No 002 OMVOH MIRIKIZUMAB-MRKZ INJECTABLE;SUBCUTANEOUS 100MG/ML No No
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 ยท 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Omvoh MIRIKIZUMAB-MRKZ Eli Lilly and Company 472cbe04-263e-433d-9a0f-58c1b50b715a 2026-06-16 Warnings, Adverse reactions Exact identifier application number: BLA761279
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents# Document, Submission type, Date table Document Submission type Date 83917 SUPPL 2025-10-27 83916 SUPPL 2025-10-27 83914 SUPPL 2025-10-24 83913 SUPPL 2025-10-24 80880 SUPPL 2025-01-21 80879 SUPPL 2025-01-21 80857 SUPPL 2025-01-16 80856 SUPPL 2025-01-16 78318 SUPPL 2024-04-30 78311 SUPPL 2024-04-30 76666 ORIG 2023-11-27 75976 ORIG 2023-10-27 75964 ORIG 2023-10-27