VITRAKVI

Bayer HealthCare Pharmaceuticals Inc.🇺🇸 United States

FDA Page

Effective Date: May 22, 2026
Approval ID: 0c8ca614-58b2-4aa4-83d3-0387a8f782fd
Products: 4 registered
Version: 21

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use VITRAKVI safely and effectively. See full prescribing information for VITRAKVI. VITRAKVI (larotrectinib) capsules, for oral use VITRAKVI (larotrectinib) oral solution Initial U.S. Approval: 2018

Quick Stats

Total Products4

Labelers2

Label Sections41

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.