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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125388
Company: SEATTLE GENETICS

Other Important Information from FDA

Summary Review

Products on BLA 125388

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

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125388

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

Labels for BLA 125388

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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