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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761269
Company: EISAI INC

Medication Guide

Summary Review

Products on BLA 761269

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
LEQEMBI	LECANEMAB-IRMB	500MG/5ML	INJECTABLE;INJECTION	Prescription	None	TBD	No
LEQEMBI	LECANEMAB-IRMB	200MG/2ML	INJECTABLE;INJECTION	Prescription	None	TBD	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761269

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/761269Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2023/761269Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2024	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761269s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761269Orig1s008ltr.pdf
07/06/2023	SUPPL-1	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761269Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/761269Orig1s001.pdf

Labels for BLA 761269

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/14/2024	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761269s008lbl.pdf
07/06/2023	SUPPL-1	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s001lbl.pdf
01/06/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761269Orig1s000lbl.pdf

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