NDA 212608

BLUEPRINT MEDICINES

FDA Drug Application

Application #212608

Documents

• Label: 2020-01-09
• Letter: 2020-01-10
• Review: 2020-02-13
• Label: 2021-06-16
• Label: 2021-06-16
• Letter: 2021-06-17
• Letter: 2021-06-17
• Review: 2022-12-09

Application Sponsors

NDA 212608

BLUEPRINT MEDICINES

Marketing Status

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

Application Products

001	TABLET;ORAL	100MG	1	AYVAKIT	AVAPRITINIB
002	TABLET;ORAL	200MG	1	AYVAKIT	AVAPRITINIB
003	TABLET;ORAL	300MG	1	AYVAKIT	AVAPRITINIB
004	TABLET;ORAL	25MG	1	AYVAKIT	AVAPRITINIB
005	TABLET;ORAL	50MG	1	AYVAKIT	AVAPRITINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2020-01-09	PRIORITY
EFFICACY; Efficacy	SUPPL	6	AP	2021-06-16	PRIORITY
EFFICACY; Efficacy	SUPPL	7	AP	2021-06-16	PRIORITY

Submissions Property Types

ORIG	1	Null	2
SUPPL	6	Null	30
SUPPL	7	Null	31

CDER Filings

BLUEPRINT MEDICINES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212608
            [companyName] => BLUEPRINT MEDICINES
            [docInserts] => ["",""]
            [products] => [{"drugName":"AYVAKIT","activeIngredients":"AVAPRITINIB","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"AYVAKIT","activeIngredients":"AVAPRITINIB","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"AYVAKIT","activeIngredients":"AVAPRITINIB","strength":"300MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"01\/09\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212608s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"01\/09\/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\\\/212608s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212608Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2020\\\/212608Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2020-01-09
        )

)