NDA 209092

NOVARTIS

FDA Drug Application

Application #209092

Documents

• Label: 2017-03-13
• Letter: 2017-03-13
• Review: 2017-03-28
• Letter: 2018-07-24
• Label: 2018-08-29
• Review: 2019-06-03
• Letter: 2019-09-11
• Label: 2019-09-11
• Letter: 2020-01-22
• Label: 2020-01-22
• Label: 2020-07-07
• Letter: 2020-07-07
• Letter: 2021-09-17
• Label: 2021-09-20
• Label: 2021-12-13
• Letter: 2021-12-16
• Letter: 2022-10-04
• Label: 2022-10-07

Application Sponsors

NDA 209092

NOVARTIS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

EQ 200MG BASE

1

KISQALI

RIBOCICLIB SUCCINATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2017-03-13	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2020-01-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	2019-09-09	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2020-07-06	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2021-12-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	2021-09-15	STANDARD
EFFICACY; Efficacy	SUPPL	13	AP	2022-10-03	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	8	Null	7
SUPPL	9	Null	6
SUPPL	13	Null	7

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209092
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"KISQALI","activeIngredients":"RIBOCICLIB SUCCINATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"10\/03\/2022","submission":"SUPPL-13","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":"12\/10\/2021","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209092s008lbl.pdf\"}]","notes":""},{"actionDate":"09\/15\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209092s009lbl.pdf\"}]","notes":""},{"actionDate":"07\/06\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209092s005lbl.pdf\"}]","notes":""},{"actionDate":"01\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209092s003lbl.pdf\"}]","notes":""},{"actionDate":"09\/09\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209092s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/18\/2018","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209092s001lbl.pdf\"}]","notes":""},{"actionDate":"03\/13\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209092s000lbl.pdf\"}]","notes":""}]
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            [supplements] => [{"actionDate":"10\/03\/2022","submission":"SUPPL-13","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":"09\/15\/2021","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209092s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"12\/10\/2021","submission":"SUPPL-8","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/209092s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/209092Orig1s008;209935Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"07\/06\/2020","submission":"SUPPL-5","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209092s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"09\/09\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/209092s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/209092Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"01\/21\/2020","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209092s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"\"}]","notes":">"},{"actionDate":"07\/18\/2018","submission":"SUPPL-1","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209092s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209092Orig1s001ltr.pdf\"},{\"name\":\"Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/209092Orig1s001.pdf\"}]","notes":">"}]
            [actionDate] => 2022-10-03
        )

)