FDA.reportPublic FDA data

Omvoh

Product NDC
0002-8011
11-digit product format
000028011
Labeler code
0002
Product ID
0002-8011_e1015232-2dfd-4b5d-b1d0-e0302e49c55a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mirikizumab-mrkz
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Eli Lilly and Company
Application
BLA761279
Marketing category
BLA
Marketing start
2023-10-26
Substance
MIRIKIZUMAB
Active strength
100 mg/mL
Pharmacologic classes
Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OmvohMIRIKIZUMAB-MRKZEli Lilly and Company472cbe04-263e-433d-9a0f-58c1b50b715a2025-11-04Warnings, Adverse reactionsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings and cautions

5 WARNINGS AND PRECAUTIONS Hypersensitivity Reactions : Serious hypersensitivity reactions, including anaphylaxis and infusion-related reactions, have been reported. If a severe hypersensitivity reaction occurs, discontinue and initiate appropriate treatment. ( 5.1 ) Infections : OMVOH may increase the risk of infection. Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. If a serious infection develops, do not administer OMVOH until the infection resolves. ( 5.2 ) Tuberculosis : Do not administer OMVOH to patients with active TB infection. Monitor patients receiving OMVOH for signs and symptoms of active TB during and after treatment. ( 5.3 ) Hepatotoxicity : Drug-induced liver injury has been reported. Monitor liver enzymes and bilirubin levels at baseline and for at least 24 weeks of treatment and thereafter according to routine patient management. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. ( 5.4 ) Immunizations : Avoid use of live vaccines. ( 5.5 ) 5.1 Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis during intravenous infusion, have been reported with OMVOH administration. Infusion-related hypersensitivity reactions, including mucocutaneous erythema and pruritus, were reported during induction [see Adverse Reactions ( 6.1 )] . If a severe hypersensitivity reaction occurs, discontinue OMVOH immediately and initiate appropriate treatment. 5.2 Infections OMVOH may increase the risk of infection [see Adverse Reactions ( 6.1 )] . Do not initiate treatment with OMVOH in patients with a clinically important active infection until the infection resolves or is adequately treated. In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing OMVOH. Instruct patients to seek medical advice if signs or symptoms of clinically important acute or chronic infection occur. If a serious infection develops or an infection is not responding to standard therapy, monitor the patient closely and do not administer OMVOH until the infection resolves. 5.3 Tuberculosis Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with OMVOH. Do not administer OMVOH to patients with active TB infection. Initiate ...

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

6 ADVERSE REACTIONS The following topics are also discussed in detail in the Warnings and Precautions section: Hypersensitivity Reactions [see Warnings and Precautions ( 5.1 )] Infections [see Warnings and Precautions ( 5.2 )] Tuberculosis [see Warnings and Precautions ( 5.3 )] Hepatotoxicity [see Warnings and Precautions ( 5.4 )] Most common adverse reactions are: Ulcerative colitis (≥2%) : Induction : upper respiratory tract infections and arthralgia. ( 6.1 ) Maintenance: upper respiratory tract infections, injection site reactions, arthralgia, rash, headache, and herpes viral infection. ( 6.1 ) Crohn's disease (≥5%) : upper respiratory tract infections, injection site reactions, headache, arthralgia, and elevated liver tests ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Ulcerative Colitis OMVOH was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction study (UC-1). In subjects who responded to induction therapy in UC-1, long term safety up to 52 weeks was evaluated in a randomized, double-blind, placebo-controlled maintenance study (UC-2) and a long-term extension study [see Clinical Studies ( 14.1 )] . In the induction study (UC-1), 1279 subjects were enrolled of whom 958 received OMVOH 300 mg administered as an intravenous infusion at Weeks 0, 4, and 8. In the maintenance study (UC-2), 581 subjects were enrolled of whom 389 received OMVOH 200 mg administered as a subcutaneous injection every 4 weeks. Table 2 summarizes the adverse reactions reported in at least 2% of subjects and at a higher frequency than placebo during UC-1. Table 2: Adverse Reactions a in Subjects with Ulcerative Colitis through Week 12 in a Placebo-Controlled Induction Study (UC-1) a Reported in at least 2% of subjects and at a higher frequency than placebo. b OMVOH 300 mg as an intravenous infusion at Weeks 0, 4, and 8. c Upper respiratory tract infections includes related terms (e.g...

adverse reactions table

Table 2: Adverse Reactionsa in Subjects with Ulcerative Colitis through Week 12 in a Placebo-Controlled Induction Study (UC-1) a Reported in at least 2% of subjects and at a higher frequency than placebo. b OMVOH 300 mg as an intravenous infusion at Weeks 0, 4, and 8. c Upper respiratory tract infections includes related terms (e.g., COVID-19, nasopharyngitis, pharyngitis, rhinitis, sinusitis, and upper respiratory tract infection). Adverse ReactionsOMVOH 300 mg Intravenous Infusionb N=958 n (%)Placebo N=321 n (%)Upper respiratory tract infectionsc72 (8%) 20 (6%) Arthralgia 20 (2%) 4 (1%)

Additional Listing Data#

Finished product
Yes
Brand name base
Omvoh
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIRIKIZUMAB100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ7HVY03PHP
Rxcui2668391, 2668398, 2668405, 2668410, 2680728, 2680732, 2703047, 2703048, 2703049, 2703050, 2703051, 2703052, 2703053, 2703054

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63103eb4-adaa-4a90-8c72-69f4cc5a37ebProduct name120250214
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0002-8011-01Omvoh1 mL in 1 SYRINGEINJECTION, SOLUTION1 mL100 mg in 1mL18
0002-8011-01Omvoh1 mL in 1 SYRINGEINJECTION, SOLUTION118
0002-8011-27Omvoh2 in 1 CARTONINJECTION, SOLUTION218
0002-8011-61Omvoh2 in 1 CARTONINJECTION, SOLUTION218
0002-8011-61Omvoh1 mL in 1 SYRINGEINJECTION, SOLUTION118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0002-8011OMVOH (MIRIKIZUMAB-MRKZ) INJECTION, SOLUTION OMVOH (MIRIKIZUMAB-MRKZ) KIT [ELI LILLY AND COMPANY]14Current NDC, 4 package rows20250406_472cbe04-263e-433d-9a0f-58c1b50b715a.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761279Omvohmirikizumab-mrkz351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2703052{1 (1 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]) } Pack [Omvoh Prefilled Pen 300 MG Dose Carton]BPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2703054{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]) } Pack [Omvoh Prefilled Syringe 300 MG Dose Carton]BPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2703051{1 (1 ML mirikizumab-mrkz 100 MG/ML Auto-Injector) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Auto-Injector) } PackGPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2703053{1 (1 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe) / 1 (2 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe) } PackGPCK472cbe04-263e-433d-9a0f-58c1b50b715a18
2668405mirikizumab-mrkz 100 MG in 1 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2680728mirikizumab-mrkz 100 MG in 1 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703049mirikizumab-mrkz 200 MG in 2 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703047mirikizumab-mrkz 200 MG in 2 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2668391mirikizumab-mrkz 300 MG in 15 ML InjectionPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703051mirikizumab-mrkz Prefilled Pen 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703053mirikizumab-mrkz Prefilled Syringe 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2668410omvoh 100 MG in 1 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2680732omvoh 100 MG in 1 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703050omvoh 200 MG in 2 ML Auto-InjectorPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703048omvoh 200 MG in 2 ML Prefilled SyringePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2668398omvoh 300 MG in 15 ML InjectionPSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703052omvoh Prefilled Pen 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
2703054omvoh Prefilled Syringe 300 MG Dose Carton - Crohn's DiseasePSN472cbe04-263e-433d-9a0f-58c1b50b715a18
26684101 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
26807321 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
266839815 ML mirikizumab-mrkz 20 MG/ML Injection [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030502 ML mirikizumab-mrkz 100 MG/ML Auto-Injector [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030482 ML mirikizumab-mrkz 100 MG/ML Prefilled Syringe [Omvoh]SBD472cbe04-263e-433d-9a0f-58c1b50b715a18
26684051 ML mirikizumab-mrkz 100 MG/ML Auto-InjectorSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
26807281 ML mirikizumab-mrkz 100 MG/ML Prefilled SyringeSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
266839115 ML mirikizumab-mrkz 20 MG/ML InjectionSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030492 ML mirikizumab-mrkz 100 MG/ML Auto-InjectorSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
27030472 ML mirikizumab-mrkz 100 MG/ML Prefilled SyringeSCD472cbe04-263e-433d-9a0f-58c1b50b715a18
26684101 ML Omvoh 100 MG/ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
266839815 ML Omvoh 20 MG/ML InjectionSY472cbe04-263e-433d-9a0f-58c1b50b715a18
27030502 ML Omvoh 100 MG/ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
27030482 ML Omvoh 100 MG/ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668405mirikizumab-mrkz 100 MG per 1 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2680728mirikizumab-mrkz 100 MG per 1 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703049mirikizumab-mrkz 200 MG per 2 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703047mirikizumab-mrkz 200 MG per 2 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668391mirikizumab-mrkz 300 MG per 15 ML InjectionSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703051mirikizumab-mrkz Prefilled Pen 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703053mirikizumab-mrkz Prefilled Syringe 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668410Omvoh 100 MG per 1 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2680732Omvoh 100 MG per 1 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703050Omvoh 200 MG per 2 ML Auto-InjectorSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703048Omvoh 200 MG per 2 ML Prefilled SyringeSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2668398Omvoh 300 MG per 15 ML InjectionSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703052Omvoh Prefilled Pen 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18
2703054Omvoh Prefilled Syringe 300 MG Dose Carton - Crohn's DiseaseSY472cbe04-263e-433d-9a0f-58c1b50b715a18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0002-8011-01000028011011 mL in 1 SYRINGE1 mlHistorical
0002-8011-27000028011272 SYRINGE in 1 CARTON (0002-8011-27) / 1 mL in 1 SYRINGE (0002-8011-01) 2 syringe2023-10-26NoNoCurrent
0002-8011-61000028011612 SYRINGE in 1 CARTON (0002-8011-61) / 1 mL in 1 SYRINGE2 syringe2024-01-16YesNoCurrent