BLA 125156

GENENTECH

FDA Drug Application

Application #125156

Documents

• Letter: 2006-07-13
• Letter: 2013-03-12
• Letter: 2014-11-28
• Letter: 2015-02-10
• Label: 2006-07-13
• Label: 2010-07-06
• Label: 2012-08-15
• Label: 2012-08-15
• Label: 2013-02-08
• Label: 2014-11-26
• Label: 2015-02-09
• Review: 2006-09-26
• Letter: 2010-07-02
• Letter: 2012-08-13
• Letter: 2012-08-13
• Letter: 2013-02-08
• Letter: 2014-03-04
• Label: 2014-03-04
• Review: 2014-01-17
• Label: 2016-10-17
• Letter: 2016-10-17
• Letter: 2016-11-25
• Label: 2016-12-01
• Label: 2017-01-06
• Letter: 2017-01-13
• Label: 2017-04-18
• Letter: 2017-04-18
• Letter: 2018-03-28
• Review: 2018-06-05
• Review: 2019-01-14
• Review: 2019-01-14
• Review: 2019-01-14
• Review: 2019-06-03
• Label: 2021-06-04

Application Sponsors

BLA 125156

GENENTECH

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

10MG/ML

0

LUCENTIS

RANIBIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2006-06-30	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2007-04-26	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2008-04-23	STANDARD
LABELING; Labeling	SUPPL	44	AP	2010-05-19	STANDARD
EFFICACY; Efficacy	SUPPL	53	AP	2010-06-22	PRIORITY
LABELING; Labeling	SUPPL	69	AP	2012-08-10	STANDARD
EFFICACY; Efficacy	SUPPL	76	AP	2012-08-10	STANDARD
EFFICACY; Efficacy	SUPPL	81	AP	2013-02-06	STANDARD
LABELING; Labeling	SUPPL	87	AP	2013-03-08	STANDARD
EFFICACY; Efficacy	SUPPL	94	AP	2014-02-27	STANDARD
EFFICACY; Efficacy	SUPPL	105	AP	2014-11-25	STANDARD
EFFICACY; Efficacy	SUPPL	106	AP	2015-02-06	PRIORITY
S; Supplement	SUPPL	110	AP	2016-10-13	UNKNOWN
EFFICACY; Efficacy	SUPPL	111	AP	2017-01-05	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	112	AP	2016-11-22	STANDARD
EFFICACY; Efficacy	SUPPL	114	AP	2017-04-15	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	117	AP	2018-03-20	N/A

Submissions Property Types

SUPPL	105	Null	7
SUPPL	106	Null	30
SUPPL	111	Null	7
SUPPL	114	Null	6
SUPPL	117	Null	7

CDER Filings

GENENTECH

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125156
            [companyName] => GENENTECH
            [docInserts] => ["",""]
            [products] => [{"drugName":"LUCENTIS","activeIngredients":"RANIBIZUMAB","strength":"10MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/15\/2017","submission":"SUPPL-114","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125156s114lbl.pdf\"}]","notes":""},{"actionDate":"01\/05\/2017","submission":"SUPPL-111","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125156s111lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2016","submission":"SUPPL-112","supplementCategories":"Manufacturing (CMC)","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125156s112lbl.pdf\"}]","notes":"This supplement type does not usually require new labeling."},{"actionDate":"10\/13\/2016","submission":"SUPPL-110","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125156s110lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2015","submission":"SUPPL-106","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125156s106lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2014","submission":"SUPPL-105","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125156s105lbl.pdf\"}]","notes":""},{"actionDate":"02\/27\/2014","submission":"SUPPL-94","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125156s094lbl.pdf\"}]","notes":""},{"actionDate":"02\/06\/2013","submission":"SUPPL-81","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125156s081lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-76","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125156s0069s0076lbl.pdf\"}]","notes":""},{"actionDate":"08\/10\/2012","submission":"SUPPL-69","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125156s0069s0076lbl.pdf\"}]","notes":""},{"actionDate":"06\/22\/2010","submission":"SUPPL-53","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/125156s053lbl.pdf\"}]","notes":""},{"actionDate":"06\/30\/2006","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125156lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/30\/2006","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2006\\\/125156lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2006\\\/125156LTR.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2006\\\/125156s0000_LucentisTOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"03\/20\/2018","submission":"SUPPL-117","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125156Orig1s117ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/125156Orig1s117.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/15\/2017","submission":"SUPPL-114","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125156s114lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125156Orig1s114ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/125156Orig1s114.pdf\"}]","notes":">"},{"actionDate":"11\/22\/2016","submission":"SUPPL-112","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125156s112lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125156Orig1s112ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125156Orig1s112.pdf\"}]","notes":">"},{"actionDate":"01\/05\/2017","submission":"SUPPL-111","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125156s111lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125156Orig1s111ltr.pdf\"}]","notes":">"},{"actionDate":"10\/13\/2016","submission":"SUPPL-110","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125156s110lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125156Orig1s110ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125156Orig1s110.pdf\"}]","notes":">"},{"actionDate":"02\/06\/2015","submission":"SUPPL-106","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125156s106lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125156Orig1s106ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125156Orig1s106.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2014","submission":"SUPPL-105","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125156s105lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125156Orig1s105ltr.pdf\"}]","notes":">"},{"actionDate":"02\/27\/2014","submission":"SUPPL-94","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125156s094lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125156Orig1s094ltr.pdf\"}]","notes":">"},{"actionDate":"03\/08\/2013","submission":"SUPPL-87","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125156Orig1s087ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/06\/2013","submission":"SUPPL-81","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125156s081lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125156Orig1s081ltr.pdf\"}]","notes":">"},{"actionDate":"08\/10\/2012","submission":"SUPPL-76","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125156s0069s0076lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125156Orig1s0069,s0076ltr.pdf\"}]","notes":">"},{"actionDate":"08\/10\/2012","submission":"SUPPL-69","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125156s0069s0076lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125156Orig1s0069,s0076ltr.pdf\"}]","notes":">"},{"actionDate":"06\/22\/2010","submission":"SUPPL-53","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2010\\\/125156s053lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125156s053ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2010\\\/125156Orig1s053.pdf\"}]","notes":">"},{"actionDate":"05\/19\/2010","submission":"SUPPL-44","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/23\/2008","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/26\/2007","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-03-20
        )

)