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FDA NDA · NDA214801

LYTGOBI

futibatinib

Sponsor: TAIHO ONCOLOGY

APPLICATION
NDA214801
TYPE
NDA
ORIGINAL APPROVAL
2022-09-30
LATEST ACTION
2025-10-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription

Products

LYTGOBI · ReferenceDiscontinued
FUTIBATINIB 16MG · TABLET · ORAL
LYTGOBI · ReferencePrescription
FUTIBATINIB 4MG · TABLET · ORAL

Approval history

2025-10-15Labeling · Supplement 5 · standard — Letter ↗AP
2024-04-17Labeling · Supplement 2 · standard — Letter ↗AP
2022-09-30Type 1 - New Molecular Entity · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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