Gomekli

🇺🇸 United States

FDA Page

Effective Date: Jul 10, 2026
Approval ID: 4c41bf90-5fa7-4935-a95c-e047ea6bbf8e
Products: 0 registered
Version: 8

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GOMEKLI safely and effectively. See full prescribing information for GOMEKLI. GOMEKLI (mirdametinib) capsules, for oral use GOMEKLI (mirdametinib) tablets for oral suspension Initial U.S. Approval: 2025

Quick Stats

Total Products0

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Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.