GENENTECH INC FDA Approval BLA 761034

Application #761034

Documents

Letter	2016-05-19
Summary Review	2016-06-21
Label	2016-05-18
Review	2016-06-21
Label	2017-04-24
Label	2018-03-14
Letter	2018-03-15
Letter	2018-05-03
Label	2018-05-03
Label	2018-06-20
Letter	2018-06-20
Letter	2018-06-21
Label	2018-06-21
Label	2018-06-28
Label	2018-07-02
Letter	2018-07-06
Letter	2018-07-06
Label	2018-12-06
Letter	2019-03-12
Label	2019-03-08
Letter	2019-03-08
Label	2019-03-19
Letter	2019-03-25
Label	2019-05-07
Label	2019-05-07
Letter	2019-05-08
Letter	2019-05-08
Medication Guide	2019-12-03
Label	2019-12-03
Letter	2019-12-04
Letter	2020-05-19
Label	2020-05-18
Label	2020-05-29
Medication Guide	2020-05-29
Letter	2020-06-02
Label	2020-07-30
Letter	2020-07-31
Letter	2020-10-01
Label	2020-10-02
Medication Guide	2020-10-02
Letter	2020-11-12
Label	2020-11-13
Medication Guide	2020-11-13
Letter	2020-12-22
Letter	2020-12-22
Label	2020-12-23
Medication Guide	2020-12-23
Label	2020-12-23
Medication Guide	2020-12-23
Review	2021-01-06
Label	2021-02-18
Label	2021-02-18
Label	2021-02-18
Label	2021-02-18
Label	2021-02-18
Label	2021-02-18
Medication Guide	2021-02-18
Letter	2021-02-18
Letter	2021-02-18
Letter	2021-02-18
Letter	2021-02-18
Letter	2021-02-18
Letter	2021-02-18
Letter	2021-04-14
Label	2021-04-16
Medication Guide	2021-04-16
Letter	2021-10-07
Label	2021-10-12
Medication Guide	2021-10-12
Letter	2021-10-20
Label	2021-10-22
Letter	2022-01-25
Label	2022-01-25
Medication Guide	2022-01-25
Label	2022-12-05
Medication Guide	2022-12-05
Label	2022-12-12
Medication Guide	2022-12-12
Letter	2022-12-12

Application Sponsors

BLA 761034

GENENTECH INC

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;INJECTION

1200MG/20ML

TECENTRIQ

ATEZOLIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-05-18	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2018-04-30	STANDARD
LABELING; Labeling	SUPPL	5	AP	2018-03-13	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2018-06-14	PRIORITY
EFFICACY; Efficacy	SUPPL	9	AP	2018-12-06	PRIORITY
EFFICACY; Efficacy	SUPPL	10	AP	2018-06-19	PRIORITY
LABELING; Labeling	SUPPL	11	AP	2018-06-26	STANDARD
EFFICACY; Efficacy	SUPPL	12	AP	2018-07-02	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	2019-05-06	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2019-05-06	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2019-03-08	PRIORITY
EFFICACY; Efficacy	SUPPL	19	AP	2019-03-18	PRIORITY
LABELING; Labeling	SUPPL	20	AP	2020-11-10	STANDARD
EFFICACY; Efficacy	SUPPL	21	AP	2019-12-03	STANDARD
EFFICACY; Efficacy	SUPPL	25	AP	2020-05-29	PRIORITY
EFFICACY; Efficacy	SUPPL	27	AP	2020-05-18	PRIORITY
EFFICACY; Efficacy	SUPPL	28	AP	2020-07-30	PRIORITY
EFFICACY; Efficacy	SUPPL	29	AP	2020-09-30	PRIORITY
EFFICACY; Efficacy	SUPPL	31	AP	2020-12-18	STANDARD
EFFICACY; Efficacy	SUPPL	32	AP	2020-12-18	STANDARD
EFFICACY; Efficacy	SUPPL	33	AP	2021-02-17	PRIORITY
EFFICACY; Efficacy	SUPPL	34	AP	2021-02-17	PRIORITY
EFFICACY; Efficacy	SUPPL	35	AP	2021-02-17	PRIORITY
EFFICACY; Efficacy	SUPPL	36	AP	2021-02-17	PRIORITY
EFFICACY; Efficacy	SUPPL	37	AP	2021-02-17	PRIORITY
EFFICACY; Efficacy	SUPPL	38	AP	2021-02-17	PRIORITY
LABELING; Labeling	SUPPL	41	AP	2021-04-13	PRIORITY
EFFICACY; Efficacy	SUPPL	42	AP	2021-10-15	PRIORITY
LABELING; Labeling	SUPPL	43	AP	2022-01-21	STANDARD
EFFICACY; Efficacy	SUPPL	44	AP	2021-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	47	AP	2022-12-09	PRIORITY
EFFICACY; Efficacy	SUPPL	50	AP	2022-12-02	PRIORITY

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	6
SUPPL	5	Null	15
SUPPL	8	Null	7
SUPPL	9	Null	15
SUPPL	10	Null	6
SUPPL	11	Null	6
SUPPL	12	Null	6
SUPPL	13	Null	7
SUPPL	14	Null	7
SUPPL	18	Null	6
SUPPL	19	Null	6
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	25	Null	15
SUPPL	27	Null	6
SUPPL	28	Null	15
SUPPL	29	Null	7
SUPPL	31	Null	15
SUPPL	32	Null	6
SUPPL	33	Null	6
SUPPL	34	Null	7
SUPPL	35	Null	7
SUPPL	36	Orphan	5
SUPPL	37	Null	6
SUPPL	38	Null	6
SUPPL	41	Null	6
SUPPL	42	Null	6
SUPPL	43	Null	15
SUPPL	44	Null	15
SUPPL	47	Null	6
SUPPL	50	Null	6

CDER Filings

GENENTECH INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761034
            [companyName] => GENENTECH INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/761034s029lbl.pdf#page=62"]
            [products] => [{"drugName":"TECENTRIQ","activeIngredients":"ATEZOLIZUMAB","strength":"1200MG\/20ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"09\/30\/2020","submission":"SUPPL-29","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761034s029lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2020","submission":"SUPPL-28","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761034s028lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2020","submission":"SUPPL-25","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761034s025lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2020","submission":"SUPPL-27","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761034s027lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2019","submission":"SUPPL-21","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2019","submission":"SUPPL-14","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s014lbl.pdf\"}]","notes":""},{"actionDate":"05\/06\/2019","submission":"SUPPL-13","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s013lbl.pdf\"}]","notes":""},{"actionDate":"03\/18\/2019","submission":"SUPPL-19","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s019lbl.pdf\"}]","notes":""},{"actionDate":"03\/08\/2019","submission":"SUPPL-18","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s018lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2018","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/02\/2018","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s012lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2018","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s011lbl.pdf\"}]","notes":""},{"actionDate":"06\/19\/2018","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/14\/2018","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s008lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s003lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s005lbl.pdf\"}]","notes":""},{"actionDate":"04\/17\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761034s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/18\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761034Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/18\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761034Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761034Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761034Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761034Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"09\/30\/2020","submission":"SUPPL-29","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761034s029lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761034Orig1s029ltr.pdf\"}]","notes":">"},{"actionDate":"07\/30\/2020","submission":"SUPPL-28","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761034s028lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761034Orig1s028ltr.pdf\"}]","notes":">"},{"actionDate":"05\/18\/2020","submission":"SUPPL-27","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761034Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"03\/18\/2019","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761034Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"03\/08\/2019","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761034Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"05\/06\/2019","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761034Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"05\/06\/2019","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761034s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761034Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"07\/02\/2018","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"06\/26\/2018","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"06\/19\/2018","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"12\/06\/2018","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034Orig1s009ltr_REPLACEMENT.pdf\"}]","notes":">"},{"actionDate":"06\/14\/2018","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034s008ltr.pdf\"}]","notes":">"},{"actionDate":"03\/13\/2018","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"04\/30\/2018","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761034s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761034Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"04\/17\/2017","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761034s001lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-30
        )

)

BLA 761034

GENENTECH INC

FDA Drug Application

Application #761034

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

GENENTECH INC