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Biologic License Application (BLA): 125388
Company: SEATTLE GENETICS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ADCETRIS BRENTUXIMAB VEDOTIN 50MG/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
08/19/2011 ORIG-1 Approval N/A; Orphan Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125388s000,125399s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388_adcetris_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
06/14/2023 SUPPL-107 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125388s107lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125388Orig1s107ltr.pdf
11/10/2022 SUPPL-106 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125388s106lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125388Orig1s106ltr.pdf
06/23/2023 SUPPL-104 Supplement Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/125388Orig1s104Correctedltr.pdf
10/15/2019 SUPPL-100 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125388s100lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125388Orig1s100ltr.pdf
11/16/2018 SUPPL-99 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s099ltr.pdf
03/20/2018 SUPPL-97 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125388Orig1s097ltr.pdf
11/09/2017 SUPPL-94 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125388Orig1s094ltr.pdf
09/28/2016 SUPPL-88 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s088ltr.pdf
03/04/2016 SUPPL-84 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s084ltr.pdf
08/17/2015 SUPPL-81 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf
08/17/2015 SUPPL-80 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf
11/23/2014 SUPPL-78 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf
11/23/2014 SUPPL-56 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf
08/19/2013 SUPPL-45 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125388Orig1s045ltr.pdf
01/13/2012 SUPPL-11 Supplement

Label is not available on this site.

08/19/2011 SUPPL-6 Supplement

Label is not available on this site.

01/13/2012 SUPPL-5 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125388s005ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
06/14/2023 SUPPL-107 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/125388s107lbl.pdf
11/10/2022 SUPPL-106 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125388s106lbl.pdf
10/15/2019 SUPPL-100 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125388s100lbl.pdf
11/16/2018 SUPPL-99 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s099lbl.pdf
03/20/2018 SUPPL-97 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125388s097lbl.pdf
11/09/2017 SUPPL-94 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125388s094lbl.pdf
09/28/2016 SUPPL-88 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf
03/04/2016 SUPPL-84 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf
08/17/2015 SUPPL-81 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
08/17/2015 SUPPL-80 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf
11/23/2014 SUPPL-78 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
11/23/2014 SUPPL-56 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf
08/19/2013 SUPPL-45 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf
01/13/2012 SUPPL-5 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf
08/19/2011 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf
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