AMGEN INC FDA Approval BLA 125522

Application #125522

Documents

Letter	2016-07-12
Letter	2016-07-12
Review	2015-10-01
Letter	2015-09-01
Label	2015-08-28
Summary Review	2015-10-01
Label	2016-12-01
Letter	2016-12-06
Label	2017-01-04
Letter	2017-01-05
Label	2017-01-25
Letter	2017-01-27
Review	2017-05-17
Review	2017-05-17
Letter	2017-12-04
Label	2017-12-04
Label	2017-12-04
Letter	2017-12-04
Letter	2018-10-26
Label	2018-10-29
Label	2019-02-19
Letter	2019-02-27
Letter	2019-02-21
Label	2019-02-27
Letter	2019-04-12
Letter	2020-05-13
Label	2021-03-01
Letter	2021-03-02
Letter	2021-09-28
Letter	2021-09-28
Label	2021-09-24
Review	2021-09-29
Letter	2022-08-17
Label	2022-08-17

Application Sponsors

BLA 125522

AMGEN INC

Marketing Status

Prescription

001

Application Products

001

INJECTABLE;INJECTION

140MG/ML

REPATHA

EVOLOCUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-08-27	STANDARD
EFFICACY; Efficacy	ORIG	2	AP	2021-02-26	STANDARD
LABELING; Labeling	SUPPL	4	AP	2016-07-08	STANDARD
LABELING; Labeling	SUPPL	8	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	9	AP	2017-01-25	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-01-03	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2017-12-01	PRIORITY
EFFICACY; Efficacy	SUPPL	14	AP	2017-12-01	STANDARD
LABELING; Labeling	SUPPL	17	AP	2018-10-18	STANDARD
LABELING; Labeling	SUPPL	19	AP	2019-02-15	STANDARD
LABELING; Labeling	SUPPL	20	AP	2019-04-11	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-02-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	2020-05-06	N/A
EFFICACY; Efficacy	SUPPL	29	AP	2021-09-24	STANDARD
LABELING; Labeling	SUPPL	31	AP	2021-09-24	STANDARD
LABELING; Labeling	SUPPL	33	AP	2022-08-16	STANDARD

Submissions Property Types

ORIG	1	Null	7
ORIG	2	Orphan	5
SUPPL	4	Null	15
SUPPL	8	Null	6
SUPPL	9	Null	6
SUPPL	11	Null	15
SUPPL	13	Null	15
SUPPL	14	Null	6
SUPPL	17	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	15
SUPPL	22	Null	7
SUPPL	29	Null	15
SUPPL	31	Null	15
SUPPL	33	Null	7

CDER Filings

AMGEN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125522
            [companyName] => AMGEN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"REPATHA","activeIngredients":"EVOLOCUMAB","strength":"140MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"02\/15\/2019","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125522s022lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125522s019lbl.pdf\"}]","notes":""},{"actionDate":"02\/15\/2019","submission":"SUPPL-19","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125522s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2018","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125522s017lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s014lbl.pdf\"}]","notes":""},{"actionDate":"12\/01\/2017","submission":"SUPPL-13","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s013lbl.pdf\"}]","notes":""},{"actionDate":"01\/25\/2017","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s009lbl.pdf\"}]","notes":""},{"actionDate":"01\/03\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s011lbl.pdf\"}]","notes":""},{"actionDate":"11\/30\/2016","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125522s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125522s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/27\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125522s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125522Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125522Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125522Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/06\/2020","submission":"SUPPL-24","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125522Orig1s024ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/15\/2019","submission":"SUPPL-22","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125522s022lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125522Orig1s022ltr.pdf\"}]","notes":">"},{"actionDate":"04\/11\/2019","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125522Orig1s020ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"02\/15\/2019","submission":"SUPPL-19","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125522s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125522Orig1s019ltr_Replacement.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2018","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125522s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125522Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"12\/01\/2017","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125522s014ltr.pdf\"}]","notes":">"},{"actionDate":"12\/01\/2017","submission":"SUPPL-13","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125522s013ltr.pdf\"}]","notes":">"},{"actionDate":"01\/03\/2017","submission":"SUPPL-11","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125522Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"01\/25\/2017","submission":"SUPPL-9","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125522s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125522Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"11\/30\/2016","submission":"SUPPL-8","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125522s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125522Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"07\/08\/2016","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125522Orig1s001,s004ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125522Orig1s004.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"07\/08\/2016","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125522Orig1s001,s004ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/125522Orig1s001.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-05-06
        )

)

BLA 125522

AMGEN INC

FDA Drug Application

Application #125522

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

AMGEN INC