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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761306
Company: ELI LILLY AND CO

Products on BLA 761306

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EBGLYSS	LEBRIKIZUMAB-LBKZ	250MG/2ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761306

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/13/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761306Orig1s000correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761306Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761306Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/09/2026	SUPPL-6	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/761306Orig1s006ltr.pdf
10/28/2025	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761306Orig1s005ltr.pdf
05/22/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761306Orig1s003ltr.pdf

Labels for BLA 761306

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/28/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s005lbl.pdf
05/22/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761306s003lbl.pdf
09/13/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761306Orig1s000correctedlbl.pdf

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