NOVARTIS FDA Approval NDA 209935

NDA 209935

NOVARTIS

FDA Drug Application

Application #209935

Documents

Label2017-05-05
Letter2017-05-09
Review2017-08-23
Label2018-04-24
Letter2018-04-24
Label2019-02-14
Letter2019-02-14
Letter2019-09-11
Label2019-09-11
Letter2020-01-22
Label2020-01-22
Label2020-07-07
Letter2020-07-07
Letter2021-09-17
Label2021-09-20
Label2021-12-13
Letter2021-12-16
Letter2022-05-25
Label2022-05-25
Letter2022-10-04
Label2022-10-07

Application Sponsors

NDA 209935NOVARTIS

Marketing Status

Prescription001

Application Products

001TABLET, TABLET;ORAL2.5MG,N/A;N/A,EQ 200MG BASE1KISQALI FEMARA CO-PACK (COPACKAGED)LETROZOLE; RIBOCICLIB SUCCINATE

FDA Submissions

TYPE 4; Type 4 - New CombinationORIG1AP2017-05-04STANDARD
EFFICACY; EfficacySUPPL2AP2019-02-13PRIORITY
LABELING; LabelingSUPPL6AP2020-01-21STANDARD
LABELING; LabelingSUPPL7AP2019-09-09STANDARD
EFFICACY; EfficacySUPPL8AP2020-07-06STANDARD
LABELING; LabelingSUPPL13AP2021-09-15STANDARD
EFFICACY; EfficacySUPPL14AP2021-12-10STANDARD
LABELING; LabelingSUPPL19AP2022-05-04STANDARD
EFFICACY; EfficacySUPPL21AP2022-10-03STANDARD

Submissions Property Types

ORIG1Null7
SUPPL2Null6
SUPPL6Null6
SUPPL7Null6
SUPPL8Null7
SUPPL13Null15
SUPPL14Null6
SUPPL19Null15
SUPPL21Null7

CDER Filings

NOVARTIS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209935
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KISQALI FEMARA CO-PACK (COPACKAGED)","activeIngredients":"LETROZOLE; RIBOCICLIB SUCCINATE","strength":"2.5MG;EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/03\/2022","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209092s013,209935s021lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2022","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209935Orig1s019lbl.pdf\"}]","notes":""},{"actionDate":"12\/10\/2021","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209935s014lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2021","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209935s013lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2020","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209935s008lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209935s006lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209935s007lbl.pdf\"}]","notes":""},{"actionDate":"02\/13\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209935s002lbl.pdf\"}]","notes":""},{"actionDate":"04\/23\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209935s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/04\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209935s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/04\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209935s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209935Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209935Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/03\/2022","submission":"SUPPL-21","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209092s013,209935s021lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209092Orig1s013,209935Orig1s021ltr.pdf\"}]","notes":">"},{"actionDate":"05\/04\/2022","submission":"SUPPL-19","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/209935Orig1s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/209935Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"12\/10\/2021","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209935s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209092Orig1s008;209935Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"09\/15\/2021","submission":"SUPPL-13","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209935s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/06\/2020","submission":"SUPPL-8","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209935s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/09\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209935s007lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209935Orig1s007ltr.pdf\"}]","notes":">"},{"actionDate":"01\/21\/2020","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209935s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"02\/13\/2019","submission":"SUPPL-2","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209935s002lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209935Orig1s002ltr.pdf\"}]","notes":">"},{"actionDate":"04\/23\/2018","submission":"SUPPL-1","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209935s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209935Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2022-10-03
        )

)
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