Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 761137
Company: ASTELLAS
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 |
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 |
|---|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|
| 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) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf |
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