BLA 125460

BIOMARIN PHARM

FDA Drug Application

Application #125460

Documents

• Letter: 2014-02-19
• Review: 2014-03-24
• Label: 2014-02-19
• Summary Review: 2014-03-24
• Letter: 2019-12-04
• Label: 2019-12-06

Application Sponsors

BLA 125460

BIOMARIN PHARM

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

5MG/5ML

0

VIMIZIM

ELOSULFASE ALFA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-02-14	PRIORITY
LABELING; Labeling	SUPPL	17	AP	2019-12-04	STANDARD

Submissions Property Types

ORIG	1	Null	2
SUPPL	17	Null	7

CDER Filings

BIOMARIN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 125460
            [companyName] => BIOMARIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"VIMIZIM","activeIngredients":"ELOSULFASE ALFA","strength":"5MG\/5ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125460s017lbl.pdf\"}]","notes":""},{"actionDate":"02\/14\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125460s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/14\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/125460s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/125460Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125460Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/125460Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"12\/04\/2019","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/125460s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/125460Orig1s017ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-12-04
        )

)