BLA 125409

GENENTECH

FDA Drug Application

Application #125409

Documents

• Letter: 2012-06-11
• Letter: 2013-10-01
• Letter: 2015-03-18
• Label: 2013-04-16
• Label: 2013-09-30
• Label: 2015-03-19
• Label: 2015-06-04
• Other: 2012-06-13
• Letter: 2013-04-16
• Letter: 2015-06-02
• Letter: 2016-03-24
• Label: 2012-06-11
• Label: 2016-03-23
• Review: 2012-07-30
• Review: 2013-10-21
• Other: 2013-10-04
• Summary Review: 2013-10-04
• Label: 2017-12-20
• Label: 2017-12-20
• Letter: 2017-12-27
• Letter: 2017-12-27
• Letter: 2018-10-01
• Label: 2018-10-17
• Label: 2018-12-20
• Letter: 2018-12-21
• Label: 2020-01-17
• Letter: 2020-01-17
• Review: 2020-03-24
• Review: 2020-03-24
• Review: 2021-12-07

Application Sponsors

BLA 125409

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

VIAL; SINGLE-USE

420MG/14ML

0

PERJETA

PERTUZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2012-06-08	PRIORITY
EFFICACY; Efficacy	SUPPL	32	AP	2013-04-12	PRIORITY
EFFICACY; Efficacy	SUPPL	51	AP	2013-09-30	PRIORITY
EFFICACY; Efficacy	SUPPL	104	AP	2015-03-17	STANDARD
LABELING; Labeling	SUPPL	105	AP	2015-05-29	STANDARD
LABELING; Labeling	SUPPL	109	AP	2016-03-22	STANDARD
EFFICACY; Efficacy	SUPPL	113	AP	2017-12-20	STANDARD
EFFICACY; Efficacy	SUPPL	118	AP	2017-12-20	PRIORITY
LABELING; Labeling	SUPPL	121	AP	2018-09-20	STANDARD
LABELING; Labeling	SUPPL	123	AP	2018-12-18	STANDARD
EFFICACY; Efficacy	SUPPL	124	AP	2020-01-16	STANDARD

Submissions Property Types

SUPPL	51	Null	41
SUPPL	104	Null	7
SUPPL	105	Null	7
SUPPL	109	Null	15
SUPPL	113	Null	6
SUPPL	118	Null	15
SUPPL	121	Null	7
SUPPL	123	Null	7
SUPPL	124	Null	7

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125409
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"PERJETA","activeIngredients":"PERTUZUMAB","strength":"420MG\/14ML","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"01\/16\/2020","submission":"SUPPL-124","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125409s124lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2018","submission":"SUPPL-123","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125409s123lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2018","submission":"SUPPL-121","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125409s121lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2017","submission":"SUPPL-118","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125409s113s118lbl.pdf\"}]","notes":""},{"actionDate":"12\/20\/2017","submission":"SUPPL-113","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125409s113s118lbl.pdf\"}]","notes":""},{"actionDate":"03\/22\/2016","submission":"SUPPL-109","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125409s109lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2015","submission":"SUPPL-105","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125409s105lbl.pdf\"}]","notes":""},{"actionDate":"03\/17\/2015","submission":"SUPPL-104","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125409s104lbl.pdf\"}]","notes":""},{"actionDate":"09\/30\/2013","submission":"SUPPL-51","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125409s051lbl.pdf\"}]","notes":""},{"actionDate":"04\/12\/2013","submission":"SUPPL-32","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125409s032lbl.pdf\"}]","notes":""},{"actionDate":"06\/08\/2012","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125409lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/08\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125409lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125409Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2012\\\/125409Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/16\/2020","submission":"SUPPL-124","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125409s124lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125409Orig1s124ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2018","submission":"SUPPL-123","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125409s123lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/20\/2018","submission":"SUPPL-121","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125409s121lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2017","submission":"SUPPL-118","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125409s113s118lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125409Orig1s113s118ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/125409Orig1s118.pdf\"}]","notes":">"},{"actionDate":"12\/20\/2017","submission":"SUPPL-113","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125409s113s118lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125409Orig1s113s118ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/125409Orig1s113.pdf\"}]","notes":">"},{"actionDate":"03\/22\/2016","submission":"SUPPL-109","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125409s109lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125409Orig1s109ltr.pdf\"}]","notes":">"},{"actionDate":"05\/29\/2015","submission":"SUPPL-105","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125409s105lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125409Orig1s105ltr.pdf\"}]","notes":">"},{"actionDate":"03\/17\/2015","submission":"SUPPL-104","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125409s104lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125409Orig1s104ltr.pdf\"}]","notes":">"},{"actionDate":"09\/30\/2013","submission":"SUPPL-51","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125409s051lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125409Orig1s051_corrected_ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125409_perjeta_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125409Orig1s051SumR.pdf\"}]","notes":">"},{"actionDate":"04\/12\/2013","submission":"SUPPL-32","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125409s032lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125409Orig1s032ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-16
        )

)