NDA 202192

INCYTE CORP

FDA Drug Application

Application #202192

Documents

• Letter: 2011-11-16
• Letter: 2012-06-25
• Letter: 2013-06-13
• Letter: 2013-11-27
• Letter: 2016-03-14
• Label: 2011-11-16
• Label: 2013-06-18
• Label: 2014-07-28
• Label: 2014-12-04
• Label: 2016-03-15
• Review: 2012-01-09
• Letter: 2014-07-28
• Letter: 2014-12-05
• Letter: 2014-12-16
• Label: 2012-06-22
• Label: 2013-11-26
• Label: 2014-12-16
• Summary Review: 2012-01-09
• Label: 2017-10-11
• Letter: 2017-10-12
• Letter: 2017-12-12
• Label: 2017-12-12
• Letter: 2018-10-29
• Label: 2018-10-30
• Label: 2019-05-24
• Letter: 2019-06-04
• Letter: 2020-01-23
• Label: 2020-01-24
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2021-09-28
• Label: 2021-09-30
• Label: 2021-09-30
• Label: 2022-12-21
• Letter: 2022-12-21

Application Sponsors

NDA 202192

INCYTE CORP

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003
• Prescription: 004
• Prescription: 005

Application Products

001	TABLET;ORAL	EQ 5MG BASE	1	JAKAFI	RUXOLITINIB PHOSPHATE
002	TABLET;ORAL	EQ 10MG BASE	1	JAKAFI	RUXOLITINIB PHOSPHATE
003	TABLET;ORAL	EQ 15MG BASE	1	JAKAFI	RUXOLITINIB PHOSPHATE
004	TABLET;ORAL	EQ 20MG BASE	1	JAKAFI	RUXOLITINIB PHOSPHATE
005	TABLET;ORAL	EQ 25MG BASE	1	JAKAFI	RUXOLITINIB PHOSPHATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2011-11-16	PRIORITY
EFFICACY; Efficacy	SUPPL	3	AP	2013-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2013-11-07	PRIORITY
LABELING; Labeling	SUPPL	5	AP	2013-11-25	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2014-07-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2014-05-30	PRIORITY
EFFICACY; Efficacy	SUPPL	8	AP	2014-12-04	PRIORITY
LABELING; Labeling	SUPPL	9	AP	2014-12-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2015-12-02	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	2015-10-06	PRIORITY
EFFICACY; Efficacy	SUPPL	12	AP	2016-03-10	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2017-10-10	STANDARD
LABELING; Labeling	SUPPL	15	AP	2017-12-06	STANDARD
LABELING; Labeling	SUPPL	16	AP	2018-10-26	STANDARD
EFFICACY; Efficacy	SUPPL	17	AP	2019-05-24	PRIORITY
LABELING; Labeling	SUPPL	19	AP	2020-01-14	STANDARD
EFFICACY; Efficacy	SUPPL	23	AP	2021-09-22	PRIORITY
LABELING; Labeling	SUPPL	25	AP	2021-09-27	STANDARD
EFFICACY; Efficacy	SUPPL	27	AP	2022-12-19	PRIORITY

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	14
SUPPL	5	Null	6
SUPPL	6	Null	6
SUPPL	7	Null	14
SUPPL	8	Null	7
SUPPL	9	Null	7
SUPPL	10	Null	14
SUPPL	11	Null	14
SUPPL	12	Null	7
SUPPL	14	Null	6
SUPPL	15	Orphan	5
SUPPL	16	Orphan	5
SUPPL	17	Null	6
SUPPL	19	Null	15
SUPPL	23	Null	15
SUPPL	25	Null	6
SUPPL	27	Null	6

CDER Filings

INCYTE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 202192
            [companyName] => INCYTE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"JAKAFI","activeIngredients":"RUXOLITINIB PHOSPHATE","strength":"EQ 5MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JAKAFI","activeIngredients":"RUXOLITINIB PHOSPHATE","strength":"EQ 10MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JAKAFI","activeIngredients":"RUXOLITINIB PHOSPHATE","strength":"EQ 15MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JAKAFI","activeIngredients":"RUXOLITINIB PHOSPHATE","strength":"EQ 20MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"JAKAFI","activeIngredients":"RUXOLITINIB PHOSPHATE","strength":"EQ 25MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/14\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202192Orig1s019Rpllbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2019","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202192s017lbl.pdf\"}]","notes":""},{"actionDate":"10\/26\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202192s016lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202192s015lbl.pdf\"}]","notes":""},{"actionDate":"12\/06\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202192s015lbl.pdf\"}]","notes":""},{"actionDate":"10\/10\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202192s014lbl.pdf\"}]","notes":""},{"actionDate":"03\/10\/2016","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202192s012lbl.pdf\"}]","notes":""},{"actionDate":"12\/15\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202192s009lbl.pdf\"}]","notes":""},{"actionDate":"12\/04\/2014","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202192s008lblPi.pdf\"}]","notes":""},{"actionDate":"07\/25\/2014","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202192s006lbl.pdf\"}]","notes":""},{"actionDate":"11\/25\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202192s005lbl.pdf\"}]","notes":""},{"actionDate":"06\/12\/2013","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202192s003lbl.pdf\"}]","notes":""},{"actionDate":"06\/21\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202192s001lbl.pdf\"}]","notes":""},{"actionDate":"11\/16\/2011","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/202192lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/16\/2011","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\\\/2011\\\/202192lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2011\\\/202192s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202192Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2011\\\/202192Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"01\/14\/2020","submission":"SUPPL-19","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/202192Orig1s019Rpllbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/202192Orig1s019ltr.pdf\"}]","notes":">"},{"actionDate":"05\/24\/2019","submission":"SUPPL-17","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/202192s017lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/202192Orig1s017ltr.pdf\"}]","notes":">"},{"actionDate":"10\/26\/2018","submission":"SUPPL-16","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/202192s016lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/202192Orig1s016ltr.pdf\"}]","notes":">"},{"actionDate":"12\/06\/2017","submission":"SUPPL-15","supplementCategories":"Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202192s015lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202192Orig1s015ltr.pdf\"}]","notes":">"},{"actionDate":"10\/10\/2017","submission":"SUPPL-14","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/202192s014lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/202192Orig1s014ltr.pdf\"}]","notes":">"},{"actionDate":"03\/10\/2016","submission":"SUPPL-12","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/202192s012lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/202192Orig1s012ltr.pdf\"}]","notes":">"},{"actionDate":"10\/06\/2015","submission":"SUPPL-11","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/02\/2015","submission":"SUPPL-10","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"12\/15\/2014","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202192s009lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202192Orig1s009ltr.pdf\"}]","notes":">"},{"actionDate":"12\/04\/2014","submission":"SUPPL-8","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202192s008lblPi.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202192Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"05\/30\/2014","submission":"SUPPL-7","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/25\/2014","submission":"SUPPL-6","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/202192s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/202192Orig1s006ltr.pdf\"}]","notes":">"},{"actionDate":"11\/25\/2013","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202192s005lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202192Orig1s005ltr.pdf\"}]","notes":">"},{"actionDate":"11\/07\/2013","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"06\/12\/2013","submission":"SUPPL-3","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/202192s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2013\\\/202192Orig1s003ltr.pdf\"}]","notes":">"},{"actionDate":"06\/21\/2012","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/202192s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2012\\\/202192s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-01-14
        )

)