BLA 761029

BIOGEN

FDA Drug Application

Application #761029

Documents

• Label: 2016-06-01
• Review: 2016-07-07
• Summary Review: 2016-07-07
• Letter: 2016-05-31
• REMS: 2017-01-13
• Label: 2017-05-31
• Medication Guide: 2017-05-31
• Letter: 2017-05-31
• Label: 2017-08-30
• Label: 2017-08-30
• Letter: 2017-08-31
• Letter: 2017-08-31
• Letter: 2017-11-07

Application Sponsors

BLA 761029

BIOGEN

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

150MG/ML

2

ZINBRYTA

DACLIZUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2016-05-27	STANDARD
LABELING; Labeling	SUPPL	2	AP	2017-08-28	STANDARD
REMS; REMS	SUPPL	5	AP	2017-11-01	N/A
LABELING; Labeling	SUPPL	7	AP	2017-08-28	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	15
SUPPL	5	Null	7
SUPPL	7	Null	7

CDER Filings

BIOGEN

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761029
            [companyName] => BIOGEN
            [docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2017\/761029s001lbl.pdf#page=24"]
            [products] => [{"drugName":"ZINBRYTA","activeIngredients":"DACLIZUMAB","strength":"150MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"08\/28\/2017","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Medication Guide","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s007lbl.pdf\"}]","notes":""},{"actionDate":"08\/28\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s007lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2017","submission":"SUPPL-1","supplementCategories":"Efficacy-Manufacturing Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/27\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761029s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/27\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/761029s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/761029Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761029Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/761029Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"08\/28\/2017","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761029Orig1s002,s007ltr.pdf\"}]","notes":">"},{"actionDate":"11\/01\/2017","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761029Orig1s005ltr.pdf\"}]","notes":"> Label is not available on this site."},{"actionDate":"08\/28\/2017","submission":"SUPPL-2","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761029Orig1s002,s007ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-1","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761029s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761029Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2017-11-01
        )

)