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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761340
Company: SAMSUNG BIOEPIS CO LTD

Medication Guide

Products on BLA 761340

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EPYSQLI	ECULIZUMAB-AAGH	300 mg/30 mL (10 mg/mL)	INJECTION;SOLUTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761340

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/19/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761340s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761340Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761340Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/10/2025	SUPPL-20	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761340Orig1s020ltr.pdf
09/02/2025	SUPPL-15	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761340Orig1s015ltr.pdf
03/12/2025	SUPPL-7	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761340Orig1s007ltr.pdf
01/28/2025	SUPPL-6	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761340Orig1s006ltr.pdf
04/30/2025	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761340Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761340Orig1s005ltr.pdf
11/15/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761340s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761340Orig1s003ltr.pdf
01/21/2025	SUPPL-2	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761340Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761340Orig1s002ltr.pdf

Labels for BLA 761340

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/30/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761340Orig1s005lbl.pdf
04/30/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761340Orig1s005lbl.pdf
01/21/2025	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761340Orig1s002lbl.pdf
01/21/2025	SUPPL-2	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761340Orig1s002lbl.pdf
11/15/2024	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761340s003lbl.pdf
11/15/2024	SUPPL-3	REMS	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761340s003lbl.pdf
07/19/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761340s000lbl.pdf

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