BIOGEN IDEC FDA Approval NDA 209531

NDA 209531

BIOGEN IDEC

FDA Drug Application

Application #209531

Documents

Label2016-12-23
Letter2016-12-23
Review2017-01-18
Label2017-11-22
Letter2017-11-27
Letter2018-05-16
Letter2018-05-16
Label2018-05-17
Label2018-05-17
Label2018-10-11
Letter2018-10-15
Letter2019-06-18
Letter2019-06-17
Label2019-06-21
Label2019-06-21
Letter2020-06-17
Label2020-06-17

Application Sponsors

NDA 209531BIOGEN IDEC

Marketing Status

Prescription001

Application Products

001SOLUTION;INTRATHECAL12MG/5ML (2.4MG/ML)1SPINRAZANUSINERSEN SODIUM

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2016-12-23PRIORITY
LABELING; LabelingSUPPL2AP2017-11-21STANDARD
EFFICACY; EfficacySUPPL3AP2018-05-14STANDARD
LABELING; LabelingSUPPL4AP2018-05-14STANDARD
LABELING; LabelingSUPPL5AP2018-10-10STANDARD
LABELING; LabelingSUPPL7AP2019-06-17STANDARD
LABELING; LabelingSUPPL8AP2019-06-17STANDARD
EFFICACY; EfficacySUPPL10AP2020-06-16STANDARD

Submissions Property Types

ORIG1Null2
SUPPL2Null7
SUPPL3Null31
SUPPL4Null15
SUPPL5Null6
SUPPL7Null31
SUPPL8Null6
SUPPL10Null7

CDER Filings

BIOGEN IDEC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209531
            [companyName] => BIOGEN IDEC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SPINRAZA","activeIngredients":"NUSINERSEN SODIUM","strength":"EQ 12MG BASE\/5ML (EQ 2.4MG BASE\/ML)","dosageForm":"SOLUTION;INTRATHECAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"06\/16\/2020","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209531s010lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209531s007s008lbl.pdf\"}]","notes":""},{"actionDate":"06\/17\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209531s007s008lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209531s005lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209531s003s004lbl.pdf\"}]","notes":""},{"actionDate":"05\/14\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209531s003s004lbl.pdf\"}]","notes":""},{"actionDate":"11\/21\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209531s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/23\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/209531lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/23\/2016","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\\\/2016\\\/209531lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/209531Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/209531Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"06\/16\/2020","submission":"SUPPL-10","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209531s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209531Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"06\/17\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209531s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209531Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"06\/17\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209531s007s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209531Orig1s007s008ltr.pdf\"}]","notes":">"},{"actionDate":"10\/10\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209531s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209531Orig1s005Ltr.pdf\"}]","notes":">"},{"actionDate":"05\/14\/2018","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209531s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209531Orig1s003s004ltr.pdf\"}]","notes":">"},{"actionDate":"05\/14\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209531s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209531Orig1s003s004ltr.pdf\"}]","notes":">"},{"actionDate":"11\/21\/2017","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209531s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209531Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-16
        )

)
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