← FDA DRUG APPROVALS

FDA NDA · NDA215039

VIJOICE

alpelisib

Sponsor: NOVARTIS

APPLICATION
NDA215039
TYPE
NDA
ORIGINAL APPROVAL
2022-04-05
LATEST ACTION
2025-07-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

VIJOICE · ReferencePrescription
ALPELISIB 200MG · TABLET · ORAL
VIJOICE · ReferencePrescription
ALPELISIB 50MG · TABLET · ORAL
VIJOICE · ReferencePrescription
ALPELISIB 125MG · TABLET · ORAL

Approval history

2025-07-22Labeling · Supplement 3 · standard — Letter ↗AP
2024-04-24Efficacy · Supplement 2 · standard — Letter ↗AP
2022-11-17Labeling · Supplement 1 · standard — Letter ↗AP
2022-04-05Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →