Drugs@FDA: FDA-Approved Drugs
Biologic License Application (BLA): 125388
Company: SEATTLE GENETICS
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 |