NOVARTIS PHARMS CORP FDA Approval BLA 761125

BLA 761125

NOVARTIS PHARMS CORP

FDA Drug Application

Application #761125

Documents

Label2019-10-08
Letter2019-10-09
Review2019-11-04
Letter2020-06-10
Label2020-06-12

Application Sponsors

BLA 761125NOVARTIS PHARMS CORP

Marketing Status

Prescription001

Application Products

001INJECTABLE; INTRAVITREAL6MG/0.05ML0BEOVUbrolucizumab-dbll

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2019-10-07PRIORITY
LABELING; LabelingSUPPL4AP2020-06-09STANDARD

Submissions Property Types

ORIG1Null7
SUPPL4Null6

CDER Filings

NOVARTIS PHARMS CORP
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761125
            [companyName] => NOVARTIS PHARMS CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEOVU","activeIngredients":"brolucizumab-dbll","strength":"6MG\/0.05ML","dosageForm":"INJECTABLE; INTRAVITREAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761125s004lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"10\/07\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761125Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761125_Orig1_toc.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/09\/2020","submission":"SUPPL-4","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761125s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761125Orig1s004ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-09
        )

)

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