ITVISMA

🇺🇸 United States

FDA Page

Effective Date: Jun 16, 2026
Approval ID: ab2e1c6c-4f95-4243-9296-1734e0a30591
Products: 0 registered
Version: 3

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ITVISMA safely and effectively. See full prescribing information for ITVISMA. ITVISMA (onasemnogene abeparvovec-brve) suspension, for intrathecal injection Initial U.S. Approval: 2025

Quick Stats

Total Products0

Labelers0

Label Sections0

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.