On this page
Omvoh
mirikizumab-mrkz
351(a) Standalone BLA
Overview
Source: Purple BookProprietary name
Omvoh
Proper name
mirikizumab-mrkz
Licence type
351(a)
BLA number
761279
Applicant
Eli Lilly and Company
Center
CDER
Presentations
5
First licensure
—
Presentations
Source: Purple Book| Strength | Dosage form | Route | Presentation | Status | Licensed |
|---|---|---|---|---|---|
| 100MG/ML | Injection | Subcutaneous | Pre-Filled Syringe | Rx | October 26, 2023 |
| 100MG/ML | Injection | Subcutaneous | Autoinjector | Rx | January 15, 2025 |
| 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Autoinjector | Rx | January 15, 2025 |
| 200MG/2ML (100MG/ML) | Injection | Subcutaneous | Pre-Filled Syringe | Rx | January 15, 2025 |
| 300MG/15ML (20MG/ML) | Injection | Intravenous | Single-Dose Vial | Rx | October 26, 2023 |
Sources for this page
| Purple Book | FDA | Licence type, presentations, reference product, exclusivity |