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FDA NDA · NDA219249

ITOVEBI

inavolisib

Sponsor: GENENTECH INC

APPLICATION
NDA219249
TYPE
NDA
ORIGINAL APPROVAL
2024-10-10
LATEST ACTION
2026-04-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ITOVEBI · ReferencePrescription
INAVOLISIB 9MG · TABLET · ORAL
ITOVEBI · ReferencePrescription
INAVOLISIB 3MG · TABLET · ORAL

Approval history

2026-04-15Efficacy · Supplement 4 · standard — Letter ↗AP
2025-09-25Labeling · Supplement 2 · standard — Letter ↗AP
2024-10-10Type 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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