REGENERON PHARMACEUTICALS FDA Approval BLA 761055

BLA 761055

REGENERON PHARMACEUTICALS

FDA Drug Application

Application #761055

Documents

Letter2017-03-30
Label2017-03-30
Review2017-05-01
Label2018-01-11
Letter2018-01-11
Label2018-04-11
Letter2018-04-12
Label2018-10-22
Letter2018-10-23
Label2019-03-11
Letter2019-03-14
Letter2019-06-27
Label2019-06-27
Review2020-02-26
Label2020-05-27
Letter2020-05-29
Letter2020-06-19
Letter2020-06-19
Label2020-06-23
Label2020-06-23
Review2020-07-22
Letter2021-06-15
Label2021-06-15
Label2021-10-01
Letter2021-10-05
Letter2021-10-22
Label2021-10-25
Letter2021-12-27
Letter2021-12-27
Letter2021-12-27
Label2021-12-27
Label2021-12-27
Label2021-12-27
Review2022-04-07
Label2022-05-23
Letter2022-05-23
Letter2022-06-08
Label2022-06-08
Review2022-07-28
Label2022-09-29
Letter2022-09-29
Label2022-10-19

Application Sponsors

BLA 761055REGENERON PHARMACEUTICALS

Marketing Status

Prescription001

Application Products

001INJECTABLE; INJECTION150MG/ML0DUPIXENTDUPILUMAB

FDA Submissions

TYPE 1; Type 1 - New Molecular EntityORIG1AP2017-03-28PRIORITY
EFFICACY; EfficacySUPPL3AP2018-04-10STANDARD
LABELING; LabelingSUPPL5AP2018-01-10STANDARD
EFFICACY; EfficacySUPPL7AP2018-10-19STANDARD
EFFICACY; EfficacySUPPL12AP2019-03-11PRIORITY
EFFICACY; EfficacySUPPL14AP2019-06-26PRIORITY
LABELING; LabelingSUPPL15AP2020-06-18STANDARD
EFFICACY; EfficacySUPPL16AP2021-06-14STANDARD
EFFICACY; EfficacySUPPL17AP2020-06-18STANDARD
EFFICACY; EfficacySUPPL20AP2020-05-26PRIORITY
LABELING; LabelingSUPPL21AP2021-12-22STANDARD
LABELING; LabelingSUPPL27AP2021-12-22STANDARD
EFFICACY; EfficacySUPPL31AP2021-10-20STANDARD
LABELING; LabelingSUPPL33AP2021-12-22STANDARD
LABELING; LabelingSUPPL35AP2021-10-01STANDARD
EFFICACY; EfficacySUPPL40AP2022-05-20PRIORITY
EFFICACY; EfficacySUPPL42AP2022-06-07PRIORITY
EFFICACY; EfficacySUPPL44AP2022-09-28PRIORITY
LABELING; LabelingSUPPL46AP2022-10-17STANDARD

Submissions Property Types

ORIG1Null6
SUPPL3Null7
SUPPL5Null7
SUPPL7Null6
SUPPL12Null15
SUPPL14Null15
SUPPL15Null6
SUPPL16Null15
SUPPL17Null15
SUPPL20Null7
SUPPL21Null6
SUPPL27Null6
SUPPL31Null15
SUPPL33Null6
SUPPL35Null7
SUPPL40Null6
SUPPL42Null30
SUPPL44Null7
SUPPL46Null7

CDER Filings

REGENERON PHARMACEUTICALS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 761055
            [companyName] => REGENERON PHARMACEUTICALS
            [docInserts] => ["",""]
            [products] => [{"drugName":"DUPIXENT","activeIngredients":"DUPILUMAB","strength":"150MG\/ML","dosageForm":"INJECTABLE; INJECTION","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/18\/2020","submission":"SUPPL-17","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s015s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s015s017lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2020","submission":"SUPPL-15","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s015s017lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2020","submission":"SUPPL-20","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s020lbl.pdf\"}]","notes":""},{"actionDate":"06\/26\/2019","submission":"SUPPL-14","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761055s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/11\/2019","submission":"SUPPL-12","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761055s012lbl.pdf\"}]","notes":""},{"actionDate":"10\/19\/2018","submission":"SUPPL-7","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761055s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/10\/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\\\/761055s003lbl.pdf\"}]","notes":""},{"actionDate":"01\/10\/2018","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761055s005lbl.pdf\"}]","notes":""},{"actionDate":"03\/28\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761055lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/28\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"N\/A","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/761055lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/761055Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/761055Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"05\/26\/2020","submission":"SUPPL-20","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s020lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761055Orig1s020ltr.pdf\"}]","notes":">"},{"actionDate":"06\/18\/2020","submission":"SUPPL-17","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s015s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761055Orig1s015,s017ltr.pdf\"}]","notes":">"},{"actionDate":"06\/18\/2020","submission":"SUPPL-15","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/761055s015s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/761055Orig1s015,s017ltr.pdf\"}]","notes":">"},{"actionDate":"06\/26\/2019","submission":"SUPPL-14","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761055s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761055Orig1s014ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/761055Orig1s014rev.pdf\"}]","notes":">"},{"actionDate":"03\/11\/2019","submission":"SUPPL-12","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/761055s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/761055Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"10\/19\/2018","submission":"SUPPL-7","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761055s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761055Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/10\/2018","submission":"SUPPL-5","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761055s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761055Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"04\/10\/2018","submission":"SUPPL-3","supplementCategories":"Supplement","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/761055s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/761055Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-06-18
        )

)
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.