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Drugs@FDA: FDA-Approved Drugs

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

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

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
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
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

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
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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