ALEXION PHARM FDA Approval BLA 125166

Application #125166

Documents

Letter	2009-08-07
Letter	2010-06-29
Letter	2014-05-02
Letter	2014-05-02
Letter	2014-10-14
Letter	2015-12-08
Label	2011-09-23
Label	2014-05-02
Label	2015-12-08
Other	2010-06-30
Letter	2007-03-27
Letter	2012-12-27
Letter	2015-12-08
Letter	2016-04-15
Label	2007-03-23
Label	2014-05-02
Review	2007-05-17
Review	2015-07-20
Label	2017-01-13
Letter	2017-01-19
Label	2017-10-23
Letter	2017-10-24
Letter	2018-03-01
Label	2018-03-06
Label	2018-07-26
Label	2018-07-26
Letter	2018-07-26
Letter	2018-07-26
Medication Guide	2018-07-31
Label	2019-07-25
Medication Guide	2019-06-28
Letter	2019-09-20
Letter	2020-04-17
Label	2020-11-23
Letter	2020-12-02
Review	2021-01-06
Review	2021-12-07

Application Sponsors

BLA 125166

ALEXION PHARM

Marketing Status

Prescription

001

Application Products

001

INJECTABLE; IV (INFUSION)

300MG

SOLIRIS

ECULIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2007-03-16	PRIORITY
LABELING; Labeling	SUPPL	33	AP	2009-06-30	STANDARD
LABELING; Labeling	SUPPL	44	AP	2010-06-04	STANDARD
EFFICACY; Efficacy	SUPPL	172	AP	2011-09-23	PRIORITY
LABELING; Labeling	SUPPL	273	AP	2012-12-21	STANDARD
EFFICACY; Efficacy	SUPPL	368	AP	2014-04-30	STANDARD
LABELING; Labeling	SUPPL	380	AP	2014-04-30	STANDARD
REMS; REMS	SUPPL	409	AP	2014-10-10	N/A
LABELING; Labeling	SUPPL	412	AP	2015-12-03	STANDARD
REMS; REMS	SUPPL	413	AP	2015-12-03	N/A
REMS; REMS	SUPPL	414	AP	2016-04-13	N/A
LABELING; Labeling	SUPPL	417	AP	2017-01-13	STANDARD
EFFICACY; Efficacy	SUPPL	422	AP	2017-10-23	STANDARD
LABELING; Labeling	SUPPL	426	AP	2018-02-28	STANDARD
LABELING; Labeling	SUPPL	427	AP	2018-07-25	STANDARD
REMS; REMS	SUPPL	428	AP	2018-07-25	N/A
EFFICACY; Efficacy	SUPPL	431	AP	2019-06-27	PRIORITY
REMS; REMS	SUPPL	432	AP	2020-04-07	N/A
LABELING; Labeling	SUPPL	434	AP	2020-11-20	STANDARD

Submissions Property Types

ORIG	1	Null	25
SUPPL	44	Null	7
SUPPL	172	Orphan	5
SUPPL	368	Orphan	5
SUPPL	380	Null	7
SUPPL	409	Null	7
SUPPL	412	Null	6
SUPPL	413	Null	6
SUPPL	414	Null	6
SUPPL	417	Null	15
SUPPL	422	Null	15
SUPPL	426	Null	15
SUPPL	427	Null	6
SUPPL	428	Null	7
SUPPL	431	Null	6
SUPPL	432	Null	6
SUPPL	434	Null	15

CDER Filings

ALEXION PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125166
            [companyName] => ALEXION PHARM
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/125166s431lbl.pdf#page=40"]
            [products] => [{"drugName":"SOLIRIS","activeIngredients":"ECULIZUMAB","strength":"300MG","dosageForm":"INJECTABLE; IV (INFUSION)","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/27\/2019","submission":"SUPPL-431","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125166s431lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2018","submission":"SUPPL-428","supplementCategories":"REMS - MODIFIED - D-N-A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s047s048lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2018","submission":"SUPPL-427","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s047s048lbl.pdf\"}]","notes":""},{"actionDate":"07\/25\/2018","submission":"SUPPL-427","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s047s048lbl.pdf\"}]","notes":""},{"actionDate":"02\/28\/2018","submission":"SUPPL-426","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s426lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2017","submission":"SUPPL-422","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125166s422lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-417","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125166s417lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-417","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125166s417lbl.pdf\"}]","notes":""},{"actionDate":"01\/13\/2017","submission":"SUPPL-417","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125166s417lbl.pdf\"}]","notes":""},{"actionDate":"12\/03\/2015","submission":"SUPPL-413","supplementCategories":"REMS-Modified","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125166s413lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2014","submission":"SUPPL-380","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125166s368s380lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2014","submission":"SUPPL-368","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125166s368s380lbl.pdf\"}]","notes":""},{"actionDate":"09\/23\/2011","submission":"SUPPL-172","supplementCategories":"Efficacy","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125166s172lbl.pdf\"}]","notes":""},{"actionDate":"03\/16\/2007","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125166lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/16\/2007","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/125166lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2007\\\/125166s0000_LTR.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2007\\\/125166s0000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/07\/2020","submission":"SUPPL-432","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125166Orig1s432ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/27\/2019","submission":"SUPPL-431","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125166s431lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125166Orig1s431ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2018","submission":"SUPPL-428","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s047s048lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125166Orig1s427s428Ltr.pdf\"}]","notes":">"},{"actionDate":"07\/25\/2018","submission":"SUPPL-427","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s047s048lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125166Orig1s427s428Ltr.pdf\"}]","notes":">"},{"actionDate":"02\/28\/2018","submission":"SUPPL-426","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125166s426lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125166Orig1s426ltr.pdf\"}]","notes":">"},{"actionDate":"10\/23\/2017","submission":"SUPPL-422","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125166s422lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125166Orig1s422ltr.pdf\"}]","notes":">"},{"actionDate":"01\/13\/2017","submission":"SUPPL-417","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/125166s417lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/125166Orig1s417ltr.pdf\"}]","notes":">"},{"actionDate":"04\/13\/2016","submission":"SUPPL-414","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125166Orig1s414ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"12\/03\/2015","submission":"SUPPL-413","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125166s413lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125166Orig1s412,s413ltr.pdf\"}]","notes":">"},{"actionDate":"12\/03\/2015","submission":"SUPPL-412","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125166Orig1s412,s413ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"10\/10\/2014","submission":"SUPPL-409","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125166Orig1s409ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"04\/30\/2014","submission":"SUPPL-380","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125166s368s380lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125166Orig1s368,125166Orig1s380ltr.pdf\"}]","notes":">"},{"actionDate":"04\/30\/2014","submission":"SUPPL-368","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125166s368s380lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125166Orig1s368,125166Orig1s380ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2012","submission":"SUPPL-273","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/125166Orig1s273ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"09\/23\/2011","submission":"SUPPL-172","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/125166s172lbl.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/bla\\\/2011\\\/125166Orig1s172-2.pdf\"}]","notes":">"},{"actionDate":"06\/04\/2010","submission":"SUPPL-44","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2010\\\/125166s044ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"06\/30\/2009","submission":"SUPPL-33","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2008\\\/125166s0033ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-04-07
        )

)

BLA 125166

ALEXION PHARM

FDA Drug Application

Application #125166

Documents

Application Sponsors

Marketing Status

Application Products

FDA Submissions

Submissions Property Types

CDER Filings

ALEXION PHARM