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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761137
Company: ASTELLAS

Patient Information Sheet

Products on BLA 761137

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PADCEV	ENFORTUMAB VEDOTIN-EJFV	20MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No
PADCEV	ENFORTUMAB VEDOTIN-EJFV	30MG/VIAL	INJECTABLE;INJECTION	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 761137

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/18/2019	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review	Accelerated Approval	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/761137Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/761137Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-25	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761137Orig1s024; s025ltr.pdf
12/15/2023	SUPPL-24	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s024s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761137Orig1s024; s025ltr.pdf
04/03/2023	SUPPL-20	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761137Orig1s020ltr.pdf
04/18/2023	SUPPL-19	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761137Orig1s019ltr.pdf
04/03/2023	SUPPL-18	Supplement	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/761137Orig1s018ltr.pdf
10/28/2022	SUPPL-17	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761137s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/761137Orig1s017ltr.pdf
07/09/2021	SUPPL-8	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761137Orig1s006, s008ltr.pdf
03/22/2021	SUPPL-7	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761137Orig1s007ltr.pdf
07/09/2021	SUPPL-6	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/761137Orig1s006, s008ltr.pdf

Labels for BLA 761137

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-25	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s024s025lbl.pdf
12/15/2023	SUPPL-24	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s024s025lbl.pdf
04/18/2023	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s019lbl.pdf
04/18/2023	SUPPL-19	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s019lbl.pdf
04/03/2023	SUPPL-20	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s020lbl.pdf
04/03/2023	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761137s020lbl.pdf
10/28/2022	SUPPL-17	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761137s017lbl.pdf
10/28/2022	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761137s017lbl.pdf
07/09/2021	SUPPL-8	Efficacy-Accelerated Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s006s008lbl.pdf
07/09/2021	SUPPL-6	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s006s008lbl.pdf
03/22/2021	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/761137s007lbl.pdf
12/18/2019	ORIG-1	Approval	Label (PDF)	Accelerated Approval	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf

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