NDA 213969

EIGER BIOPHARMS

FDA Drug Application

Application #213969

Documents

• Label: 2020-11-25
• Review: 2020-12-18
• Letter: 2020-12-23

Application Sponsors

NDA 213969

EIGER BIOPHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	CAPSULE;ORAL	50MG	1	ZOKINVY	LONAFARNIB
002	CAPSULE;ORAL	75MG	1	ZOKINVY	LONAFARNIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2020-11-20

PRIORITY

Submissions Property Types

ORIG

1

Null

30

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
        )

)