NDA 213721

BLUEPRINT MEDICINES

FDA Drug Application

Application #213721

Documents

• Label: 2020-09-08
• Letter: 2020-09-08
• Review: 2020-09-29
• Letter: 2021-11-12
• Label: 2021-11-12
• Letter: 2022-02-03
• Label: 2022-02-04
• Label: 2022-10-11

Application Sponsors

NDA 213721

BLUEPRINT MEDICINES

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

100MG

2

GAVRETO

PRALSETINIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	SUPPL	1	AP	2020-09-04	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2021-11-10	STANDARD
LABELING; Labeling	SUPPL	5	AP	2022-02-02	STANDARD
LABELING; Labeling	SUPPL	7	AP	2022-09-28	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	4	Null	15
SUPPL	5	Null	15
SUPPL	7	Null	7

CDER Filings

BLUEPRINT MEDICINES

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213721
            [companyName] => BLUEPRINT MEDICINES
            [docInserts] => ["",""]
            [products] => [{"drugName":"GAVRETO","activeIngredients":"PRALSETINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","supplementCategories":"Type 1 - New Molecular Entity","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213721s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","actionType":"","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":""}]
            [supplements] => [{"actionDate":"09\/04\/2020","submission":"SUPPL-1","supplementCategories":"","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/213721s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/213721Orig1s000ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2020-09-04
        )

)