ABBVIE INC FDA Approval NDA 209394

NDA 209394

ABBVIE INC

FDA Drug Application

Application #209394

Documents

Label2017-08-07
Letter2017-08-07
Review2017-09-13
Summary Review2017-09-13
Label2017-12-13
Letter2017-12-18
Label2018-08-07
Letter2018-08-07
Letter2019-04-30
Label2019-05-01
Letter2019-09-27
Letter2019-09-27
Label2019-10-02
Label2019-10-02
Label2020-04-13
Letter2020-04-13
Pediatric CDTL Review1900-01-01
Pediatric Medical Addendum1900-01-01
Pediatric Clinical Pharmacology Review1900-01-01
Pediatric Statistical Review1900-01-01
Pediatric Other1900-01-01
Label2021-06-11
Letter2021-06-14
Letter2021-09-29
Label2021-10-01

Application Sponsors

NDA 209394ABBVIE INC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL100MG;40MG1MAVYRETGLECAPREVIR; PIBRENTASVIR

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New CombinationORIG1AP2017-08-03PRIORITY
EFFICACY; EfficacySUPPL2AP2018-08-06STANDARD
LABELING; LabelingSUPPL3AP2017-12-11STANDARD
EFFICACY; EfficacySUPPL6AP2019-04-30PRIORITY
EFFICACY; EfficacySUPPL7AP2019-09-26STANDARD
EFFICACY; EfficacySUPPL8AP2019-09-26PRIORITY
EFFICACY; EfficacySUPPL10AP2020-04-10STANDARD
EFFICACY; EfficacySUPPL13AP2021-06-10PRIORITY
LABELING; LabelingSUPPL14AP2021-09-28STANDARD

Submissions Property Types

ORIG1Null6
SUPPL2Null6
SUPPL3Null6
SUPPL6Null7
SUPPL7Null15
SUPPL8Null6
SUPPL10Null31
SUPPL13Null6
SUPPL14Null6

CDER Filings

ABBVIE INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209394
            [companyName] => ABBVIE INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MAVYRET","activeIngredients":"GLECAPREVIR; PIBRENTASVIR","strength":"100MG;40MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/10\/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\\\/209394s010lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2019","submission":"SUPPL-8","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209394s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/26\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209394s007lbl.pdf\"}]","notes":""},{"actionDate":"04\/30\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209394s006lbl.pdf\"}]","notes":""},{"actionDate":"08\/06\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209394s002lbl.pdf\"}]","notes":""},{"actionDate":"12\/11\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209394s003lbl.pdf\"}]","notes":""},{"actionDate":"08\/03\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209394s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/03\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209394s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209394Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209394_toc.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209394Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"04\/10\/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\\\/209394s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209394Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"09\/26\/2019","submission":"SUPPL-8","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209394s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209394Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"09\/26\/2019","submission":"SUPPL-7","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209394s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209394Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"04\/30\/2019","submission":"SUPPL-6","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209394s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209394Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"12\/11\/2017","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209394s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209394Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"08\/06\/2018","submission":"SUPPL-2","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209394s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209394Orig1s002ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-04-10
        )

)
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