BIOGEN INC FDA Approval BLA 761178

BLA 761178

BIOGEN INC

FDA Drug Application

Application #761178

Documents

Label2021-06-07
Medication Guide2021-06-07
Letter2021-06-07

Application Sponsors

BLA 761178BIOGEN INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTION170MG/1.7ML (100MG/ML)2ADUHELMADUCANUMAB-AVWA
002INJECTABLE;INJECTION300MG/3ML (100MG/ML)2ADUHELMADUCANUMAB-AVWA

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2021-06-07PRIORITY

Submissions Property Types

ORIG1Null7

CDER Filings

BIOGEN INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761178
            [companyName] => BIOGEN INC
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2021\/761178s000lbl.pdf#page=21"]
            [products] => [{"drugName":"ADUHELM","activeIngredients":"ADUCANUMAB-AVWA","strength":"170MG\/1.7ML (100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"},{"drugName":"ADUHELM","activeIngredients":"ADUCANUMAB-AVWA","strength":"300MG\/3ML (100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/07\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761178s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/07\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/761178s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/761178Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-07
        )

)

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.