ASTELLAS FDA Approval BLA 761137

BLA 761137

ASTELLAS

FDA Drug Application

Application #761137

Documents

Label2019-12-19
Letter2019-12-20
Review2020-01-08

Application Sponsors

BLA 761137ASTELLAS

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION20MG/VIAL0PADCEVENFORTUMAB VEDOTIN-EJFV
002INJECTABLE;INJECTION30MG/VIAL0PADCEVENFORTUMAB VEDOTIN-EJFV

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2019-12-18PRIORITY

Submissions Property Types

ORIG1Null15

CDER Filings

ASTELLAS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761137
            [companyName] => ASTELLAS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PADCEV","activeIngredients":"ENFORTUMAB VEDOTIN-EJFV","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"PADCEV","activeIngredients":"ENFORTUMAB VEDOTIN-EJFV","strength":"30MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"12\/18\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761137s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/18\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761137s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761137Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761137Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-12-18
        )

)

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