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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761425
Company: SAMSUNG BIOEPIS CO LTD

Medication Guide

Summary Review

Products on BLA 761425

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PYZCHIVA	USTEKINUMAB-TTWE	130MG/26ML(5MG/ML)	INJECTABLE;SUBCUTANEOUS	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761425

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/30/2025	ORIG-2	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373Orig2s000,761425Orig2s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761373Orig2s000; 761425Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761373Orig2s000,761425Orig2s000TOC.html
06/28/2024	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373Orig1s001;761425Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761373Orig1s000;761425Orig1s000correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761373Orig1s000,761425Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2025	SUPPL-5	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s006,761425s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/761373Orig1s006;761425Orig1s005ltr.pdf
03/13/2025	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s003,761425s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761373Orig1s003, 761425Orig1s003ltr.pdf
12/20/2024	SUPPL-2	Supplement	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s002,761425s002lbl.pdf
12/20/2024	SUPPL-1	Supplement	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373Orig1s001;761425Orig1s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/761373Orig1s001;761425Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2025/761373Orig1Orig2s001,761425Orig1Orig2s001CrossR.pdf

Labels for BLA 761425

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/18/2025	SUPPL-5	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s006,761425s005lbl.pdf
11/18/2025	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s006,761425s005lbl.pdf
04/30/2025	ORIG-2	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373Orig2s000,761425Orig2s000lbl.pdf
03/13/2025	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s003,761425s003lbl.pdf
03/13/2025	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373s003,761425s003lbl.pdf
12/20/2024	SUPPL-2	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761373s002,761425s002lbl.pdf
12/20/2024	SUPPL-1	Manufacturing (CMC)-Control	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373Orig1s001;761425Orig1s001lbl.pdf
06/28/2024	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761373Orig1s001;761425Orig1s001lbl.pdf

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