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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 212526
Company: NOVARTIS

Products on NDA 212526

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PIQRAY	ALPELISIB	50MG	TABLET;ORAL	Prescription	None	Yes	No
PIQRAY	ALPELISIB	150MG	TABLET;ORAL	Prescription	None	Yes	No
PIQRAY	ALPELISIB	200MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 212526

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/24/2019	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212526s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212526Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/212526Orig1s000TOC.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2024	SUPPL-9	Efficacy-New Indication	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212526s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/212526Orig1s009ltr.pdf
11/22/2022	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212526Orig1s007ltr.pdf
05/04/2022	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/212526Orig1s006ltr.pdf
07/20/2021	SUPPL-4	Labeling-Patient Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212526Orig1s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212526Orig1s004ltr.pdf
09/01/2020	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212526s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/212526Orig1s001ltr.pdf

Labels for NDA 212526

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/18/2024	SUPPL-9	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/212526s009lbl.pdf
11/22/2022	SUPPL-7	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s007lbl.pdf
05/04/2022	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/212526s006lbl.pdf
07/20/2021	SUPPL-4	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212526Orig1s004lbl.pdf
09/01/2020	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/212526s001lbl.pdf
05/24/2019	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212526s000lbl.pdf

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