XOLAIR

Genentech, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 13, 2026
Approval ID: 7f6a2191-adfb-48b9-9bfa-0d9920479f0d
Products: 4 registered
Version: 32

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XOLAIR safely and effectively. See full prescribing information for XOLAIR. XOLAIR (omalizumab) injection, for subcutaneous use XOLAIR (omalizumab) for injection, for subcutaneous use Initial U.S. Approval: 2003

Quick Stats

Total Products4

Labelers2

Label Sections48

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.