GENENTECH FDA Approval BLA 125427

BLA 125427

GENENTECH

FDA Drug Application

Application #125427

Documents

Letter2013-08-22
Letter2013-09-03
Letter2015-06-02
Letter2016-05-02
Label2013-02-22
Label2013-08-30
Review2013-02-28
Other Important Information from FDA2014-02-07
Summary Review2013-02-22
Letter2013-02-22
Letter2014-07-15
Letter2016-07-26
Label2013-08-21
Label2014-07-15
Label2015-06-04
Label2016-04-29
Label2016-07-27
Letter2018-10-01
Label2018-10-17
Label2018-12-20
Letter2018-12-21
Label2019-05-03
Letter2019-05-06
Letter2020-09-29
Label2020-09-29
Letter2022-02-03
Label2022-02-04

Application Sponsors

BLA 125427GENENTECH

Marketing Status

Prescription001
Prescription002

Application Products

001VIAL; SINGLE-USE100MG0KADCYLAADO-TRASTUZUMAB EMTANSINE
002VIAL; SINGLE-USE160MG0KADCYLAADO-TRASTUZUMAB EMTANSINE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2013-02-22PRIORITY
LABELING; LabelingSUPPL12AP2013-08-19STANDARD
LABELING; LabelingSUPPL14AP2013-08-29STANDARD
LABELING; LabelingSUPPL33AP2014-07-11STANDARD
LABELING; LabelingSUPPL87AP2015-05-29STANDARD
LABELING; LabelingSUPPL94AP2016-04-28STANDARD
LABELING; LabelingSUPPL96AP2016-07-25STANDARD
LABELING; LabelingSUPPL102AP2018-09-20STANDARD
LABELING; LabelingSUPPL104AP2018-12-18STANDARD
EFFICACY; EfficacySUPPL105AP2019-05-03PRIORITY
LABELING; LabelingSUPPL108AP2020-09-27STANDARD
LABELING; LabelingSUPPL111AP2022-02-02STANDARD

Submissions Property Types

ORIG1Null2
SUPPL87Null7
SUPPL94Null6
SUPPL96Null15
SUPPL102Null7
SUPPL104Null7
SUPPL105Null30
SUPPL108Null6
SUPPL111Null7

CDER Filings

GENENTECH
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125427
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"KADCYLA","activeIngredients":"ADO-TRASTUZUMAB EMTANSINE","strength":"100MG","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"KADCYLA","activeIngredients":"ADO-TRASTUZUMAB EMTANSINE","strength":"160MG","dosageForm":"VIAL; SINGLE-USE","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/27\/2020","submission":"SUPPL-108","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125427s108lbl.pdf\"}]","notes":""},{"actionDate":"05\/03\/2019","submission":"SUPPL-105","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125427s105lbl.pdf\"}]","notes":""},{"actionDate":"12\/18\/2018","submission":"SUPPL-104","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125427s104lbl.pdf\"}]","notes":""},{"actionDate":"09\/20\/2018","submission":"SUPPL-102","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125427s102lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2016","submission":"SUPPL-96","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125427s096lbl.pdf\"}]","notes":""},{"actionDate":"04\/28\/2016","submission":"SUPPL-94","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125427s094lbledt.pdf\"}]","notes":""},{"actionDate":"05\/29\/2015","submission":"SUPPL-87","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125427s087lbl.pdf\"}]","notes":""},{"actionDate":"07\/11\/2014","submission":"SUPPL-33","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125427s033lbl.pdf\"}]","notes":""},{"actionDate":"08\/29\/2013","submission":"SUPPL-14","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125427Orig1s014Lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2013","submission":"SUPPL-12","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125427s012lbl.pdf\"}]","notes":""},{"actionDate":"02\/22\/2013","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125427lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/22\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125427lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125427Orig1s000Approv.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125427Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125427Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/27\/2020","submission":"SUPPL-108","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125427s108lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125427Orig1s108ltr.pdf\"}]","notes":">"},{"actionDate":"05\/03\/2019","submission":"SUPPL-105","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125427s105lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125427Orig1s105ltr.pdf\"}]","notes":">"},{"actionDate":"12\/18\/2018","submission":"SUPPL-104","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125427s104lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/20\/2018","submission":"SUPPL-102","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125427s102lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/103792Orig1s5344,125409Orig1s121,125427Orig1s102ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2016","submission":"SUPPL-96","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125427s096lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125427Orig1s096ltr.pdf\"}]","notes":">"},{"actionDate":"04\/28\/2016","submission":"SUPPL-94","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125427s094lbledt.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125427Orig1s094ltr.pdf\"}]","notes":">"},{"actionDate":"05\/29\/2015","submission":"SUPPL-87","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125427s087lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125427Orig1s087ltr.pdf\"}]","notes":">"},{"actionDate":"07\/11\/2014","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125427s033lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125427Orig1s033ltr.pdf\"}]","notes":">"},{"actionDate":"08\/29\/2013","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125427Orig1s014Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125427Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"08\/19\/2013","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125427s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125427Orig1s012ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-27
        )

)
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