BLA 125276

GENENTECH

FDA Drug Application

Application #125276

Documents

• Letter: 2012-06-22
• Letter: 2013-05-01
• Letter: 2013-07-05
• Letter: 2014-11-14
• Label: 2010-01-12
• Label: 2011-01-11
• Label: 2011-01-11
• Label: 2011-04-18
• Label: 2011-04-18
• Label: 2012-08-15
• Label: 2013-05-01
• Label: 2013-10-21
• Review: 2010-03-09
• Review: 2012-12-28
• Summary Review: 2010-03-09
• Letter: 2010-01-26
• Letter: 2011-01-07
• Letter: 2011-01-07
• Letter: 2011-05-26
• Letter: 2011-05-26
• Letter: 2012-08-15
• Letter: 2012-10-15
• Letter: 2013-10-22
• Letter: 2015-08-21
• Label: 2011-01-11
• Label: 2012-10-15
• Label: 2016-09-27
• Letter: 2016-09-26
• Label: 2017-03-31
• Letter: 2017-04-03
• Label: 2017-05-24
• Letter: 2017-05-24
• Label: 2017-08-30
• Letter: 2017-08-31
• Review: 2017-12-06
• Review: 2018-02-14
• Label: 2018-03-22
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Letter: 2018-03-28
• Review: 2018-04-13
• Label: 2018-05-14
• Letter: 2018-05-16
• Label: 2018-05-21
• Letter: 2018-05-21
• Label: 2018-09-13
• Letter: 2018-09-14
• Label: 2018-11-20
• Letter: 2018-11-20
• Label: 2018-12-21
• Label: 2019-04-12
• Label: 2019-04-12
• Letter: 2019-04-15
• Letter: 2019-04-15
• Letter: 2019-06-12
• Medication Guide: 2019-06-12
• Label: 2019-06-12
• Label: 2020-05-29
• Medication Guide: 2020-05-29
• Letter: 2020-06-01
• Letter: 2021-03-08
• Label: 2021-03-09
• Medication Guide: 2021-03-09
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Other: 1900-01-01
• Review: 2021-04-07
• Letter: 2021-10-25
• Letter: 2022-03-01
• Label: 2022-03-01
• Medication Guide: 2022-03-01
• Label: 2022-12-22
• Medication Guide: 2022-12-22
• Letter: 2022-12-22

Application Sponsors

BLA 125276

GENENTECH

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE; INJECTION	80MG/4ML	0	ACTEMRA	TOCILIZUMAB
002	INJECTABLE; INJECTION	200MG/10ML	0	ACTEMRA	TOCILIZUMAB
003	INJECTABLE; INJECTION	400MG/20ML	0	ACTEMRA	TOCILIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2010-01-08	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2011-01-04	STANDARD
EFFICACY; Efficacy	SUPPL	10	AP	2011-01-04	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2011-01-04	STANDARD
EFFICACY; Efficacy	SUPPL	22	AP	2011-04-15	PRIORITY
LABELING; Labeling	SUPPL	23	AP	2011-04-15	STANDARD
LABELING; Labeling	SUPPL	46	AP	2012-08-13	STANDARD
LABELING; Labeling	SUPPL	48	AP	2012-06-20	STANDARD
EFFICACY; Efficacy	SUPPL	49	AP	2012-10-11	STANDARD
EFFICACY; Efficacy	SUPPL	64	AP	2013-04-29	STANDARD
LABELING; Labeling	SUPPL	75	AP	2013-07-02	STANDARD
LABELING; Labeling	SUPPL	92	AP	2013-10-21	STANDARD
LABELING; Labeling	SUPPL	105	AP	2014-11-13	STANDARD
REMS; REMS	SUPPL	106	AP	2015-08-18	N/A
EFFICACY; Efficacy	SUPPL	107	AP	2016-09-23	STANDARD
LABELING; Labeling	SUPPL	111	AP	2017-03-30	STANDARD
LABELING; Labeling	SUPPL	112	AP	2017-05-22	STANDARD
EFFICACY; Efficacy	SUPPL	114	AP	2017-08-30	PRIORITY
EFFICACY; Efficacy	SUPPL	115	AP	2018-05-11	PRIORITY
LABELING; Labeling	SUPPL	116	AP	2018-03-22	STANDARD
LABELING; Labeling	SUPPL	117	AP	2018-05-17	STANDARD
LABELING; Labeling	SUPPL	118	AP	2018-11-19	STANDARD
EFFICACY; Efficacy	SUPPL	120	AP	2019-04-11	STANDARD
EFFICACY; Efficacy	SUPPL	121	AP	2019-04-11	STANDARD
LABELING; Labeling	SUPPL	122	AP	2018-09-12	STANDARD
LABELING; Labeling	SUPPL	125	AP	2018-12-20	STANDARD
LABELING; Labeling	SUPPL	127	AP	2019-06-11	901 REQUIRED
LABELING; Labeling	SUPPL	129	AP	2020-05-28	STANDARD
LABELING; Labeling	SUPPL	131	AP	2021-03-04	STANDARD
EFFICACY; Efficacy	SUPPL	134	AP	2022-02-28	STANDARD
LABELING; Labeling	SUPPL	135	AP	2021-10-22	STANDARD
EFFICACY; Efficacy	SUPPL	138	AP	2022-12-21	PRIORITY

Submissions Property Types

SUPPL	23	Null	7
SUPPL	48	Null	7
SUPPL	75	Null	7
SUPPL	92	Null	7
SUPPL	105	Null	7
SUPPL	106	Null	15
SUPPL	107	Null	6
SUPPL	111	Null	6
SUPPL	112	Null	6
SUPPL	114	Null	7
SUPPL	115	Null	7
SUPPL	116	Null	7
SUPPL	117	Null	15
SUPPL	118	Null	6
SUPPL	120	Null	15
SUPPL	121	Null	6
SUPPL	122	Null	6
SUPPL	125	Null	15
SUPPL	127	Null	15
SUPPL	129	Null	7
SUPPL	131	Null	7
SUPPL	134	Null	6
SUPPL	135	Null	15
SUPPL	138	Null	6

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125276
            [companyName] => GENENTECH
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2020\/125276s129,125472s042lbl.pdf#page=46"]
            [products] => [{"drugName":"ACTEMRA","activeIngredients":"TOCILIZUMAB","strength":"80MG\/4ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ACTEMRA","activeIngredients":"TOCILIZUMAB","strength":"200MG\/10ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"ACTEMRA","activeIngredients":"TOCILIZUMAB","strength":"400MG\/20ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"05\/28\/2020","submission":"SUPPL-129","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125276s129,125472s042lbl.pdf\"}]","notes":""},{"actionDate":"06\/11\/2019","submission":"SUPPL-127","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125276s127,125472s040lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-121","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125276s120s121lbl.pdf\"}]","notes":""},{"actionDate":"04\/11\/2019","submission":"SUPPL-120","supplementCategories":"Efficacy-Labeling Change With Clinical 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125276s0046lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2011","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s0022s0023lbl.pdf\"}]","notes":""},{"actionDate":"04\/15\/2011","submission":"SUPPL-22","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s0022s0023lbl.pdf\"}]","notes":""},{"actionDate":"01\/04\/2011","submission":"SUPPL-11","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label 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            [originalApprovals] => [{"actionDate":"01\/08\/2010","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/125276lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125276s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/125276s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2010\\\/125276s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/28\/2020","submission":"SUPPL-129","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125276s129,125472s042lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125472Orig1s042,125276Orig1s129ltr.pdf\"}]","notes":">"},{"actionDate":"06\/11\/2019","submission":"SUPPL-127","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125276s127,125472s040lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/20\/2018","submission":"SUPPL-125","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label 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(PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125276Orig1s115,125472Orig1s028ltr.pdf\"}]","notes":">"},{"actionDate":"08\/30\/2017","submission":"SUPPL-114","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125276s114lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125276Orig1s114ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/125276Orig1s114TOC.cfm\"}]","notes":">"},{"actionDate":"05\/22\/2017","submission":"SUPPL-112","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125276s112lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125276Orig1s112ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/125276Orig1s112.pdf\"}]","notes":">"},{"actionDate":"03\/30\/2017","submission":"SUPPL-111","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125276s111,125472s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125276Orig1s111,125472Orig1s023ltr.pdf\"}]","notes":">"},{"actionDate":"09\/23\/2016","submission":"SUPPL-107","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125276s107_125472s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125276Orig1s107,125472Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"08\/18\/2015","submission":"SUPPL-106","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125276s106,125472s014ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"11\/13\/2014","submission":"SUPPL-105","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125276Orig1s105ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/21\/2013","submission":"SUPPL-92","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125276s092lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125276Orig1s092ltr.pdf\"}]","notes":">"},{"actionDate":"07\/02\/2013","submission":"SUPPL-75","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125276Orig1s075ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/29\/2013","submission":"SUPPL-64","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125276s064lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125276Orig1s064ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125276Orig1s064.pdf\"}]","notes":">"},{"actionDate":"10\/11\/2012","submission":"SUPPL-49","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125276s0049lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125276Orig1s0049ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2012\\\/125276Orig1s049TOC.cfm\"}]","notes":">"},{"actionDate":"06\/20\/2012","submission":"SUPPL-48","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125276s0048ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/13\/2012","submission":"SUPPL-46","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125276s0046lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125276Orig1s0046ltr.pdf\"}]","notes":">"},{"actionDate":"04\/15\/2011","submission":"SUPPL-23","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s0022s0023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125276s0022,s0023ltr.pdf\"}]","notes":">"},{"actionDate":"04\/15\/2011","submission":"SUPPL-22","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s0022s0023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125276s0022,s0023ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2011","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s007s010s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125276s007,s010,s011ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2011","submission":"SUPPL-10","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s007s010s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125276s007,s010,s011ltr.pdf\"}]","notes":">"},{"actionDate":"01\/04\/2011","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125276s007s010s011lbl.pdf\"}]","notes":">"}]
            [actionDate] => 2020-05-28
        )

)