EIGER BIOPHARMS FDA Approval NDA 213969

NDA 213969

EIGER BIOPHARMS

FDA Drug Application

Application #213969

Documents

Label2020-11-25
Review2020-12-18
Letter2020-12-23

Application Sponsors

NDA 213969EIGER BIOPHARMS

Marketing Status

Prescription001
Prescription002

Application Products

001CAPSULE;ORAL50MG1ZOKINVYLONAFARNIB
002CAPSULE;ORAL75MG1ZOKINVYLONAFARNIB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-11-20PRIORITY

Submissions Property Types

ORIG1Null30

CDER Filings

EIGER BIOPHARMS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213969
            [companyName] => EIGER BIOPHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOKINVY","activeIngredients":"LONAFARNIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ZOKINVY","activeIngredients":"LONAFARNIB","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/20\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213969s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/20\/2020","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\\\/2020\\\/213969s000lbl.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-11-20
        )

)

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