Lundbeck Seattle BioPharmaceuticals, Inc. FDA Approval BLA 761119

BLA 761119

Lundbeck Seattle BioPharmaceuticals, Inc.

FDA Drug Application

Application #761119

Documents

Label2020-02-24
Letter2020-02-24
Review2020-03-23

Application Sponsors

BLA 761119Lundbeck Seattle BioPharmaceuticals, Inc.

Marketing Status

Prescription001

Application Products

001INJECTABLE;INJECTION100MG/ML0VYEPTIEPTINEZUMAB-JJMR

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2020-02-21STANDARD

Submissions Property Types

ORIG1Null6

CDER Filings

Lundbeck Seattle BioPharmaceuticals, Inc.
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761119
            [companyName] => Lundbeck Seattle BioPharmaceuticals, Inc.
            [docInserts] => ["",""]
            [products] => [{"drugName":"VYEPTI","activeIngredients":"EPTINEZUMAB-JJMR","strength":"100MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"02\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761119s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761119s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761119Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/761119Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-02-21
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.