NDA 213736

INCYTE CORP

FDA Drug Application

Application #213736

Documents

• Label: 2020-04-20
• Letter: 2020-04-20
• Review: 2020-05-18
• Label: 2021-02-24
• Letter: 2021-02-24
• Label: 2022-08-26
• Letter: 2022-08-29

Application Sponsors

NDA 213736

INCYTE CORP

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	4.5MG	2	PEMAZYRE	PEMIGATINIB
002	TABLET;ORAL	9MG	2	PEMAZYRE	PEMIGATINIB
003	TABLET;ORAL	13.5MG	2	PEMAZYRE	PEMIGATINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-04-17	PRIORITY
EFFICACY; Efficacy	SUPPL	2	AP	2022-08-26	PRIORITY

Submissions Property Types

ORIG	1	Null	30
SUPPL	2	Null	6

CDER Filings

INCYTE CORP

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213736
            [companyName] => INCYTE CORP
            [docInserts] => ["",""]
            [products] => [{"drugName":"PEMAZYRE","activeIngredients":"PEMIGATINIB","strength":"4.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PEMAZYRE","activeIngredients":"PEMIGATINIB","strength":"9MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PEMAZYRE","activeIngredients":"PEMIGATINIB","strength":"13.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"04\/17\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213736s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/17\/2020","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\\\/2020\\\/213736s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213736Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/213736Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-04-17
        )

)