BLA 761178

BIOGEN INC

FDA Drug Application

Application #761178

Documents

• Label: 2021-06-07
• Medication Guide: 2021-06-07
• Letter: 2021-06-07
• Review: 2021-06-22
• Label: 2021-07-08
• Letter: 2021-07-08
• Label: 2022-05-02
• Letter: 2022-05-03

Application Sponsors

BLA 761178

BIOGEN INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INJECTABLE;INJECTION	170MG/1.7ML (100MG/ML)	2	ADUHELM	ADUCANUMAB-AVWA
002	INJECTABLE;INJECTION	300MG/3ML (100MG/ML)	2	ADUHELM	ADUCANUMAB-AVWA

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-06-07	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2021-07-07	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	5	Null	15

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
        )

)