GENGLYCOS

Ultragenyx Pharmaceutical Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 28, 2026
Approval ID: ef9144f5-10c3-47d9-a7c6-ab5ff11e9bf8
Products: 0 registered
Version: 4

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use GENGLYCOS safely and effectively. See full prescribing information for GENGLYCOS. GENGLYCOS™ (pariglasgene brecaparvovec-opnr) suspension for intravenous infusion Initial U.S. Approval: 2026

Quick Stats

Total Products0

Labelers1

Label Sections30

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.