BLA 125561

ALEXION PHARM

FDA Drug Application

Application #125561

Documents

• Letter: 2015-12-08
• Label: 2015-12-08
• Review: 2016-01-06
• Label: 2021-11-22
• Letter: 2021-11-23

Application Sponsors

BLA 125561

ALEXION PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/10ML

0

KANUMA

SEBELIPASE ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2015-12-08	PRIORITY
EFFICACY; Efficacy	SUPPL	13	AP	2021-11-19	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	13	Null	7

CDER Filings

ALEXION PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125561
            [companyName] => ALEXION PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"KANUMA","activeIngredients":"SEBELIPASE ALFA","strength":"20MG\/10ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/08\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/125561s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/08\/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\\\/125561s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/125561Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/125561Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2015-12-08
        )

)