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Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 125409
Company: GENENTECH

Cross Discipline Team Leader Review

Summary Review

Summary Review

Products on BLA 125409

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PERJETA	PERTUZUMAB	420MG/14ML	VIAL; SINGLE-USE	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for BLA 125409

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/08/2012	ORIG-1	Approval		N/A	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125409Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/125409Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2020	SUPPL-124	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/125409Orig1s124ltr.pdf
12/18/2018	SUPPL-123	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125409s123lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/125409Orig1s123, 125427Orig1s104ltr.pdf
09/20/2018	SUPPL-121	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125409s121lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf
12/20/2017	SUPPL-118	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125409Orig1s113s118ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125409Orig1s118.pdf
12/20/2017	SUPPL-113	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/125409Orig1s113s118ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/125409Orig1s113.pdf
03/22/2016	SUPPL-109	Supplement	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125409Orig1s109ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/125409Orig1s109.pdf
05/29/2015	SUPPL-105	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s105ltr.pdf
03/17/2015	SUPPL-104	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125409Orig1s104ltr.pdf
09/30/2013	SUPPL-51	Supplement	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s051_corrected_ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409_perjeta_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/125409Orig1s051SumR.pdf
04/12/2013	SUPPL-32	Supplement	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125409Orig1s032ltr.pdf

Labels for BLA 125409

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/16/2020	SUPPL-124	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/125409s124lbl.pdf
12/18/2018	SUPPL-123	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125409s123lbl.pdf
09/20/2018	SUPPL-121	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/125409s121lbl.pdf
12/20/2017	SUPPL-118	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf
12/20/2017	SUPPL-113	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125409s113s118lbl.pdf
03/22/2016	SUPPL-109	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125409s109lbl.pdf
05/29/2015	SUPPL-105	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s105lbl.pdf
03/17/2015	SUPPL-104	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125409s104lbl.pdf
09/30/2013	SUPPL-51	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s051lbl.pdf
04/12/2013	SUPPL-32	Efficacy	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125409s032lbl.pdf
06/08/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125409lbl.pdf

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