BIOMARIN PHARM FDA Approval NDA 214938

NDA 214938

BIOMARIN PHARM

FDA Drug Application

Application #214938

Documents

Label2021-11-22
Letter2021-11-23

Application Sponsors

NDA 214938BIOMARIN PHARM

Marketing Status

Prescription001
Prescription002
Prescription003

Application Products

001INJECTABLE;INJECTION0.4MG0VOXZOGOVOSORITIDE
002INJECTABLE;INJECTION0.56MG0VOXZOGOVOSORITIDE
003INJECTABLE;INJECTION1.2MG0VOXZOGOVOSORITIDE

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-11-19PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

BIOMARIN PHARM
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214938
            [companyName] => BIOMARIN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"VOXZOGO","activeIngredients":"VOSORITIDE","strength":"0.4MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VOXZOGO","activeIngredients":"VOSORITIDE","strength":"0.56MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"VOXZOGO","activeIngredients":"VOSORITIDE","strength":"1.2MG","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/19\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214938s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/19\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214938s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214938Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-11-19
        )

)

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