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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761133
Company: TAKEDA PHARMS USA

Medication Guide

Products on BLA 761133

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTYVIO	VEDOLIZUMAB	300MG	INJECTABLE;INTRAVENOUS	Prescription	None	No	No
ENTYVIO	VEDOLIZUMAB	108MG/0.68ML	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761133

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/2023	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761133s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761133Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/18/2024	SUPPL-6	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf
04/18/2024	SUPPL-5	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/761359Orig1s000; 761133Orig1s005; s006; 125476Orig1s060; s061ltr.pdf
03/14/2024	SUPPL-4	Supplement	Label (PDF) Letter		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125476Orig1s058, 761133Orig1s004ltr.pd
02/23/2024	SUPPL-3	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/125476Orig1s054; 761133Orig1s003ltr.pdf

Labels for BLA 761133

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/14/2024	SUPPL-4	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf
03/14/2024	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s058,761133s004lbl.pdf
02/23/2024	SUPPL-3	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf
02/23/2024	SUPPL-3	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125476s054,761133s003lbl.pdf
09/27/2023	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761133s000lbl.pdf

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