← FDA DRUG APPROVALS

FDA NDA · NDA220305

KOMZIFTI

ziftomenib

Sponsor: KURA

APPLICATION
NDA220305
TYPE
NDA
ORIGINAL APPROVAL
2025-11-13
LATEST ACTION
2025-11-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

KOMZIFTI · ReferencePrescription
ZIFTOMENIB 200MG · CAPSULE · ORAL

Approval history

2025-11-13Type 1 - New Molecular Entity · Original · priorityLetterAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →