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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 761137
Company: ASTELLAS
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
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
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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