← FDA DRUG APPROVALS

FDA NDA · NDA219304

ROMVIMZA

vimseltinib

Sponsor: DECIPHERA PHARMS

APPLICATION
NDA219304
TYPE
NDA
ORIGINAL APPROVAL
2025-02-14
LATEST ACTION
2026-06-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

ROMVIMZA · ReferencePrescription
VIMSELTINIB 20MG · CAPSULE · ORAL
ROMVIMZA · ReferencePrescription
VIMSELTINIB 30MG · CAPSULE · ORAL
ROMVIMZA · ReferencePrescription
VIMSELTINIB 14MG · CAPSULE · ORAL

Approval history

2026-06-26Efficacy · Supplement 2 · standard — Letter ↗AP
2025-12-12Labeling · Supplement 1 · standard — Letter ↗AP
2025-02-14Type 1 - New Molecular Entity · Original · priority — Letter ↗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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