BLA 125513

ALEXION PHARM

FDA Drug Application

Application #125513

Documents

• Review: 2015-12-03
• Letter: 2015-10-26
• Label: 2015-10-26
• Summary Review: 2015-12-03
• Letter: 2016-10-20
• Label: 2017-02-22
• Label: 2018-01-30
• Letter: 2018-01-30
• Label: 2020-06-15
• Letter: 2020-06-16

Application Sponsors

BLA 125513

ALEXION PHARM

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004

Application Products

001	SOLUTION;INJECTION	18MG/0.45ML	0	STRENSIQ	ASFOTASE ALFA
002	SOLUTION;INJECTION	28MG/0.7ML	0	STRENSIQ	ASFOTASE ALFA
003	SOLUTION;INJECTION	40MG/ML	0	STRENSIQ	ASFOTASE ALFA
004	SOLUTION;INJECTION	80MG/0.8ML	0	STRENSIQ	ASFOTASE ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-10-23	PRIORITY
LABELING; Labeling	SUPPL	2	AP	2016-10-18	STANDARD
LABELING; Labeling	SUPPL	3	AP	2018-01-26	STANDARD
EFFICACY; Efficacy	SUPPL	18	AP	2020-06-12	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	15
SUPPL	3	Null	15
SUPPL	18	Null	6

CDER Filings

ALEXION PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125513
            [companyName] => ALEXION PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"STRENSIQ","activeIngredients":"ASFOTASE ALFA","strength":"18MG\/0.45ML","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"STRENSIQ","activeIngredients":"ASFOTASE ALFA","strength":"28MG\/0.7ML","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"STRENSIQ","activeIngredients":"ASFOTASE ALFA","strength":"40MG\/ML","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"STRENSIQ","activeIngredients":"ASFOTASE ALFA","strength":"80MG\/0.8ML","dosageForm":"SOLUTION;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/12\/2020","submission":"SUPPL-18","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125513s018lbl.pdf\"}]","notes":""},{"actionDate":"01\/26\/2018","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125513s003lbl.pdf\"}]","notes":""},{"actionDate":"10\/18\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125513s002lbl.pdf\"}]","notes":""},{"actionDate":"10\/23\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125513s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/23\/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\\\/125513s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125513Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125513Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125513Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/12\/2020","submission":"SUPPL-18","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/125513s018lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/125513Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"01\/26\/2018","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/125513s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/125513Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"10\/18\/2016","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/125513s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/125513Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-12
        )

)