Zolgensma

Novartis Gene Therapies, Inc.🇺🇸 United States

FDA Page

Effective Date: Jun 16, 2026
Approval ID: 68cd4f06-70e1-40d8-bedb-609ec0afa471
Products: 0 registered
Version: 16

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ZOLGENSMA safely and effectively. See full prescribing information for ZOLGENSMA. ZOLGENSMA (onasemnogene abeparvovec-xioi) suspension, for intravenous infusionInitial U.S. Approval: 2019

Quick Stats

Total Products0

Labelers1

Label Sections56

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.