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FDA NDA · NDA212526

PIQRAY

alpelisib

Sponsor: NOVARTIS

APPLICATION
NDA212526
TYPE
NDA
ORIGINAL APPROVAL
2019-05-24
LATEST ACTION
2024-01-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PIQRAY · ReferencePrescription
ALPELISIB 150MG · TABLET · ORAL
PIQRAY · ReferencePrescription
ALPELISIB 200MG · TABLET · ORAL
PIQRAY · ReferencePrescription
ALPELISIB 50MG · TABLET · ORAL

Approval history

2024-01-18Efficacy · Supplement 9 · priority — Letter ↗AP
2022-11-22Efficacy · Supplement 7 · standard — Label ↗AP
2022-05-04Labeling · Supplement 6 · standard — Letter ↗AP
2021-07-20Labeling · Supplement 4 · standard — Label ↗AP
2020-09-01Labeling · Supplement 1 · standard — Letter ↗AP
2019-05-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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