NDA 212526

NOVARTIS

FDA Drug Application

Application #212526

Documents

• Label: 2019-05-24
• Letter: 2019-06-17
• Review: 2019-06-18
• Letter: 2020-09-02
• Label: 2020-09-04
• Label: 2021-07-21
• Letter: 2021-07-22
• Letter: 2022-05-05
• Label: 2022-05-06
• Label: 2022-11-23
• Letter: 2022-11-25

Application Sponsors

NDA 212526

NOVARTIS

Marketing Status

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

Application Products

001	TABLET;ORAL	50MG	1	PIQRAY	ALPELISIB
002	TABLET;ORAL	150MG	1	PIQRAY	ALPELISIB
003	TABLET;ORAL	200MG	1	PIQRAY	ALPELISIB

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2019-05-24	PRIORITY
LABELING; Labeling	SUPPL	4	AP	2021-07-20	STANDARD
LABELING; Labeling	SUPPL	6	AP	2022-05-04	STANDARD
EFFICACY; Efficacy	SUPPL	7	AP	2022-11-22	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	4	Null	7
SUPPL	6	Null	15
SUPPL	7	Null	6

CDER Filings

NOVARTIS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212526
            [companyName] => NOVARTIS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIQRAY","activeIngredients":"ALPELISIB","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PIQRAY","activeIngredients":"ALPELISIB","strength":"150MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"PIQRAY","activeIngredients":"ALPELISIB","strength":"200MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"07\/20\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212526Orig1s004lbl.pdf\"}]","notes":""},{"actionDate":"09\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212526s001lbl.pdf\"}]","notes":""},{"actionDate":"05\/24\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212526s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/24\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212526s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212526Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/212526Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"07\/20\/2021","submission":"SUPPL-4","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/212526Orig1s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/212526Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"09\/01\/2020","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212526s001lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212526Orig1s001ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2021-07-20
        )

)