NDA 205755

NOVARTIS

FDA Drug Application

Application #205755

Documents

• Letter: 2015-07-23
• Label: 2014-04-29
• Label: 2015-07-24
• Summary Review: 2014-05-16
• Letter: 2014-04-30
• Letter: 2015-07-23
• Label: 2015-07-24
• Review: 2014-05-16
• Label: 2016-09-09
• Letter: 2016-09-08
• Letter: 2017-05-31
• Label: 2017-06-02
• Label: 2017-07-20
• Letter: 2017-07-21
• Label: 2017-11-21
• Letter: 2017-11-27
• Label: 2017-12-26
• Letter: 2017-12-27
• Letter: 2019-03-14
• Label: 2019-03-07
• Label: 2021-08-22
• Letter: 2021-08-24
• Letter: 2021-10-12
• Label: 2021-10-13

Application Sponsors

NDA 205755

NOVARTIS

Marketing Status

• Discontinued: 001

Application Products

001

CAPSULE;ORAL

150MG

1

ZYKADIA

CERITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2014-04-29	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	2015-06-24	PRIORITY
LABELING; Labeling	SUPPL	3	AP	2015-07-22	STANDARD
LABELING; Labeling	SUPPL	4	AP	2015-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	2015-08-25	PRIORITY
LABELING; Labeling	SUPPL	6	AP	2016-09-07	STANDARD
EFFICACY; Efficacy	SUPPL	9	AP	2017-05-26	PRIORITY
EFFICACY; Efficacy	SUPPL	10	AP	2017-12-21	STANDARD
LABELING; Labeling	SUPPL	11	AP	2017-11-20	STANDARD
LABELING; Labeling	SUPPL	12	AP	2017-07-19	STANDARD
LABELING; Labeling	SUPPL	16	AP	2019-03-05	STANDARD
LABELING; Labeling	SUPPL	18	AP	2021-08-19	STANDARD
LABELING; Labeling	SUPPL	19	AP	2021-10-07	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	2	Null	0
SUPPL	3	Null	6
SUPPL	4	Null	6
SUPPL	5	Null	0
SUPPL	6	Null	15
SUPPL	9	Null	7
SUPPL	10	Orphan	5
SUPPL	11	Null	15
SUPPL	12	Null	6
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205755
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZYKADIA","activeIngredients":"CERITINIB","strength":"150MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/07\/2021","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205755s019lbl.pdf\"}]","notes":""},{"actionDate":"10\/07\/2021","submission":"SUPPL-19","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205755s019lbl.pdf\"}]","notes":""},{"actionDate":"08\/19\/2021","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205755s018.pdf\"}]","notes":""},{"actionDate":"03\/05\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205755s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/21\/2017","submission":"SUPPL-10","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s010lbl.pdf\"}]","notes":""},{"actionDate":"11\/20\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s011lbl.pdf\"}]","notes":""},{"actionDate":"07\/19\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s012lbl.pdf\"}]","notes":""},{"actionDate":"05\/26\/2017","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s009lbl.pdf\"}]","notes":""},{"actionDate":"09\/07\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205755s006lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205755s003s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205755s003s004lbl.pdf\"}]","notes":""},{"actionDate":"07\/22\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205755s003s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/29\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205755s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/29\/2014","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\\\/2014\\\/205755s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205755Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205755Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205755Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/07\/2021","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205755s019lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/205755Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"08\/19\/2021","submission":"SUPPL-18","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/205755s018.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/205755Orig1s018ltr.pdf\"}]","notes":">"},{"actionDate":"03\/05\/2019","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/205755s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/205755Orig1s016ltr_REPLACEMENT.pdf\"}]","notes":">"},{"actionDate":"07\/19\/2017","submission":"SUPPL-12","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205755Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"11\/20\/2017","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s011lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205755Orig1s011ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2017","submission":"SUPPL-10","supplementCategories":"Efficacy-New Dosing Regimen","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s010lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205755Orig1s010ltr.pdf\"}]","notes":">"},{"actionDate":"05\/26\/2017","submission":"SUPPL-9","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/205755s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/205755Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"09\/07\/2016","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/205755s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/205755Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"08\/25\/2015","submission":"SUPPL-5","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/22\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert, Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205755s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205755Orig1s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"07\/22\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/205755s003s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205755Orig1s003,s004ltr.pdf\"}]","notes":">"},{"actionDate":"06\/24\/2015","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/30\/2014","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2021-10-07
        )

)