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Omvoh

mirikizumab-mrkz · Kit

Prescription Biologic BLA
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Omvoh
Generic name
mirikizumab-mrkz
Dosage form
Kit
Route
Subcutaneous
Marketing category
BLA · BLA
Labeler
Eli Lilly and Company
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
0
NDC product codes
2
Packages
3
Data completeness
52% of corroborating sources present

Forms, strengths and routes

Source: NDC Directory
Dosage form
Kit
Route of administration
Subcutaneous
Presentations
5

Regulatory status

Source: Drugs@FDANDC Directory
Application number
761279
Application type
BLA · Biologics License Application
Approval date
October 26, 2023
Sponsor
ELI LILLY AND CO
Products on application
2
Submissions recorded
5
Products approved under application 761279.
Product Trade name Form Strength Ingredient Status TE Flags
761279-001 OMVOH VIAL MIRIKIZUMAB-MRKZ Prescription —
761279-002 OMVOH INJECTABLE MIRIKIZUMAB-MRKZ Prescription —

Approval history

Source: Drugs@FDA
Most recent submissions on application 761279.
Type No. Action Status Date Review
Supplement 5 Labeling Approved October 23, 2025 Standard
Supplement 3 Efficacy Approved January 15, 2025 Standard
Supplement 2 Efficacy Approved January 15, 2025 Standard
Supplement 1 Labeling Approved April 29, 2024 Standard
Original application 1 Type 1 - New Molecular Entity Approved October 26, 2023 Standard

Review documents

  • 0 · Supplement · October 27, 2025
  • 0 · Supplement · October 27, 2025
  • 0 · Supplement · October 24, 2025
  • 0 · Supplement · October 24, 2025
  • 0 · Supplement · January 21, 2025
  • 0 · Supplement · January 21, 2025
  • 0 · Supplement · January 16, 2025
  • 0 · Supplement · January 16, 2025
  • 0 · Supplement · April 30, 2024
  • 0 · Supplement · April 30, 2024
  • 0 · Original application · November 27, 2023
  • 0 · Original application · October 27, 2023
  • 0 · Original application · October 27, 2023

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
0002-7717-11 0002-7717 Eli Lilly and Company 1 KIT in 1 CARTON (0002-7717-11) * 1 mL in 1 SYRINGE * 2 mL in 1 SYRINGE * 1 mL in 1 SYRINGE (0002-8011-01) * 2 mL in 1 SYRINGE (0002-3116-01) January 15, 2025
0002-7717-61 0002-7717 Eli Lilly and Company 1 KIT in 1 CARTON (0002-7717-61) * 1 mL in 1 SYRINGE * 2 mL in 1 SYRINGE * 1 mL in 1 SYRINGE (0002-8011-01) * 2 mL in 1 SYRINGE (0002-3116-01) January 15, 2025
0002-7722-11 0002-7722 Eli Lilly and Company 1 KIT in 1 CARTON (0002-7722-11) * 1 mL in 1 SYRINGE (0002-8870-01) * 2 mL in 1 SYRINGE (0002-1442-01) January 15, 2025
0002-7717 0002-7717 Eli Lilly and Company — January 15, 2025
0002-7722 0002-7722 Eli Lilly and Company — January 15, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Purple Book FDA Biologic licence classification

Generated September 25, 2026 · 7 sections on this page.