BLA 125387

REGENERON PHARMACEUTICALS

FDA Drug Application

Application #125387

Documents

• Letter: 2011-11-22
• Letter: 2012-09-24
• Letter: 2014-01-28
• Letter: 2014-07-31
• Letter: 2014-10-08
• Letter: 2015-03-26
• Label: 2014-01-28
• Label: 2015-08-04
• Label: 2015-03-26
• Label: 2016-05-25
• Review: 2012-01-10
• Summary Review: 2012-01-10
• Letter: 2013-06-11
• Letter: 2013-06-11
• Letter: 2015-08-04
• Letter: 2016-05-25
• Label: 2011-11-21
• Label: 2012-09-25
• Label: 2013-06-11
• Label: 2013-06-11
• Label: 2014-10-09
• Letter: 2016-10-26
• Label: 2016-10-31
• Label: 2017-05-31
• Letter: 2017-05-31
• Label: 2018-08-17
• Label: 2018-08-17
• Letter: 2018-08-20
• Letter: 2018-08-20
• Review: 2019-01-14
• Review: 2019-08-07
• Label: 2019-05-14
• Letter: 2019-05-15
• Label: 2019-10-15
• Review: 2020-03-19
• Review: 2020-03-24
• Review: 2020-03-24
• Review: 2020-05-08
• Letter: 2021-03-31
• Label: 2021-04-01
• Review: 2021-09-24
• Letter: 2022-09-07
• Label: 2022-09-07

Application Sponsors

BLA 125387

REGENERON PHARMACEUTICALS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE; INJECTION

40MG/ML

0

EYLEA

AFLIBERCEPT

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-11-18	PRIORITY
EFFICACY; Efficacy	SUPPL	4	AP	2012-09-21	STANDARD
LABELING; Labeling	SUPPL	15	AP	2013-06-07	STANDARD
LABELING; Labeling	SUPPL	20	AP	2013-06-07	STANDARD
LABELING; Labeling	SUPPL	23	AP	2014-01-27	STANDARD
LABELING; Labeling	SUPPL	36	AP	2015-07-30	STANDARD
EFFICACY; Efficacy	SUPPL	37	AP	2014-07-29	STANDARD
EFFICACY; Efficacy	SUPPL	43	AP	2014-10-06	STANDARD
EFFICACY; Efficacy	SUPPL	48	AP	2015-03-25	PRIORITY
LABELING; Labeling	SUPPL	51	AP	2016-05-24	STANDARD
LABELING; Labeling	SUPPL	52	AP	2016-10-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	53	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	54	AP	2017-05-26	STANDARD
EFFICACY; Efficacy	SUPPL	56	AP	2018-08-16	STANDARD
LABELING; Labeling	SUPPL	58	AP	2018-08-16	STANDARD
LABELING; Labeling	SUPPL	60	AP	2019-08-12	STANDARD
EFFICACY; Efficacy	SUPPL	61	AP	2019-05-13	STANDARD
LABELING; Labeling	SUPPL	69	AP	2021-03-30	STANDARD
LABELING; Labeling	SUPPL	76	AP	2022-09-06	STANDARD

Submissions Property Types

SUPPL	36	Null	15
SUPPL	37	Null	15
SUPPL	43	Null	7
SUPPL	48	Null	7
SUPPL	51	Null	6
SUPPL	52	Null	6
SUPPL	54	Null	7
SUPPL	56	Null	15
SUPPL	58	Null	15
SUPPL	61	Null	7
SUPPL	69	Null	15
SUPPL	76	Null	6

CDER Filings

REGENERON PHARMACEUTICALS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125387
            [companyName] => REGENERON PHARMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"EYLEA","activeIngredients":"AFLIBERCEPT","strength":"40MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"08\/12\/2019","submission":"SUPPL-60","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125387s060lbl.pdf\"}]","notes":""},{"actionDate":"05\/13\/2019","submission":"SUPPL-61","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125387s061lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2018","submission":"SUPPL-58","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125387s056s058lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2018","submission":"SUPPL-58","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125387s056s058lbl.pdf\"}]","notes":""},{"actionDate":"08\/16\/2018","submission":"SUPPL-56","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125387s056s058lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2017","submission":"SUPPL-54","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125387s054lbl.pdf\"}]","notes":""},{"actionDate":"10\/24\/2016","submission":"SUPPL-52","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125387s052lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2016","submission":"SUPPL-51","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125387s051lbl.pdf\"}]","notes":""},{"actionDate":"07\/30\/2015","submission":"SUPPL-36","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125387s036lbl.pdf\"}]","notes":""},{"actionDate":"03\/25\/2015","submission":"SUPPL-48","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125387s048lbl.pdf\"}]","notes":""},{"actionDate":"10\/06\/2014","submission":"SUPPL-43","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125387s043lbl.pdf\"}]","notes":""},{"actionDate":"01\/27\/2014","submission":"SUPPL-23","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125387s023lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2013","submission":"SUPPL-20","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125387s015s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/07\/2013","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125387s015s020lbl.pdf\"}]","notes":""},{"actionDate":"09\/21\/2012","submission":"SUPPL-4","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125387s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/18\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125387lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/18\/2011","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125387lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/125387s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125387s0000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/125387Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/13\/2019","submission":"SUPPL-61","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125387s061lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125387Orig1s061ltr.pdf\"}]","notes":">"},{"actionDate":"08\/12\/2019","submission":"SUPPL-60","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125387s060lbl.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/125387Orig1s060.pdf\"}]","notes":">"},{"actionDate":"08\/16\/2018","submission":"SUPPL-58","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125387s056s058lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125387Orig2s056s058Ltr.pdf\"}]","notes":">"},{"actionDate":"08\/16\/2018","submission":"SUPPL-56","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125387s056s058lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125387Orig2s056s058Ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-54","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125387s054lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125387Orig1s054ltr.pdf\"}]","notes":">"},{"actionDate":"10\/28\/2016","submission":"SUPPL-53","supplementCategories":"Supplement","inserts":"[{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/125387Orig1s053.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/24\/2016","submission":"SUPPL-52","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125387s052lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125387Orig1s052ltr.pdf\"}]","notes":">"},{"actionDate":"05\/24\/2016","submission":"SUPPL-51","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125387s051lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125387Orig1s051ltr.pdf\"}]","notes":">"},{"actionDate":"03\/25\/2015","submission":"SUPPL-48","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125387s048lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125387Orig1s048ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125387Orig1s048.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2014","submission":"SUPPL-43","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125387s043lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125387Orig1s043ltr.pdf\"}]","notes":">"},{"actionDate":"07\/29\/2014","submission":"SUPPL-37","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125387Orig1s037ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/30\/2015","submission":"SUPPL-36","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125387s036lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125387Orig1s036ltr.pdf\"}]","notes":">"},{"actionDate":"01\/27\/2014","submission":"SUPPL-23","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125387s023lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125387Orig1s023ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125387Orig1s023.pdf\"}]","notes":">"},{"actionDate":"06\/07\/2013","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125387s015s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125387Orig1s015,125387Orig1s020ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125387Orig1s020.pdf\"}]","notes":">"},{"actionDate":"06\/07\/2013","submission":"SUPPL-15","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/125387s015s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/125387Orig1s015,125387Orig1s020ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2013\\\/125387Orig1s015.pdf\"}]","notes":">"},{"actionDate":"09\/21\/2012","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/125387s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125387Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-08-12
        )

)