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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125427
Company: GENENTECH

Other Important Information from FDA

Summary Review

Products on BLA 125427

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KADCYLA	ADO-TRASTUZUMAB EMTANSINE	100MG	VIAL; SINGLE-USE	Prescription	None	No	No
KADCYLA	ADO-TRASTUZUMAB EMTANSINE	160MG	VIAL; SINGLE-USE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125427

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/22/2013	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000Approv.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125427Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2022	SUPPL-111	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/125427Orig1s111ltr.pdf
09/27/2020	SUPPL-108	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125427s108lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125427Orig1s108ltr.pdf
05/03/2019	SUPPL-105	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/125427Orig1s105ltr.pdf
12/18/2018	SUPPL-104	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125427s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125409Orig1s123, 125427Orig1s104ltr.pdf
09/20/2018	SUPPL-102	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125427s102lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf
07/25/2016	SUPPL-96	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s096ltr.pdf
04/28/2016	SUPPL-94	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s094lbledt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125427Orig1s094ltr.pdf
05/29/2015	SUPPL-87	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125427s087lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125427Orig1s087ltr.pdf
07/11/2014	SUPPL-33	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125427s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125427Orig1s033ltr.pdf
08/29/2013	SUPPL-14	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s014ltr.pdf
08/19/2013	SUPPL-12	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125427Orig1s012ltr.pdf

Labels for BLA 125427

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/02/2022	SUPPL-111	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/125427s111lbl.pdf
09/27/2020	SUPPL-108	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125427s108lbl.pdf
05/03/2019	SUPPL-105	Efficacy-Manufacturing Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/125427s105lbl.pdf
12/18/2018	SUPPL-104	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125427s104lbl.pdf
09/20/2018	SUPPL-102	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125427s102lbl.pdf
07/25/2016	SUPPL-96	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s096lbl.pdf
04/28/2016	SUPPL-94	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125427s094lbledt.pdf
05/29/2015	SUPPL-87	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125427s087lbl.pdf
07/11/2014	SUPPL-33	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125427s033lbl.pdf
08/29/2013	SUPPL-14	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427Orig1s014Lbl.pdf
08/19/2013	SUPPL-12	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427s012lbl.pdf
02/22/2013	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125427lbl.pdf

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