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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761279
Company: ELI LILLY AND CO

Medication Guide

Products on BLA 761279

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OMVOH	MIRIKIZUMAB-MRKZ	300MG/15ML	VIAL; SINGLE-USE	Prescription	None	No	No
OMVOH	MIRIKIZUMAB-MRKZ	100MG/ML	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761279

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/26/2023	ORIG-1	Approval		N/A; Orphan	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761279s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761279Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761279Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2025	SUPPL-5	Supplement	Label (PDF) Letter (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761279Orig1s005ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761279Orig1s005ltr.pdf
01/15/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761279Orig1s003ltr.pdf
01/15/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761279Orig1s002ltr.pdf
04/29/2024	SUPPL-1	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761279s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761279Orig1s001ltr.pdf

Labels for BLA 761279

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/23/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s005lbl.pdf
10/23/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s005lbl.pdf
10/23/2025	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s005lbl.pdf
01/15/2025	SUPPL-3	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s003lbl.pdf
01/15/2025	SUPPL-2	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761279s002lbl.pdf
04/29/2024	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761279s001lbl.pdf
04/29/2024	SUPPL-1	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761279s001lbl.pdf
04/29/2024	SUPPL-1	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761279s001lbl.pdf
10/26/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761279s000lbl.pdf

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