Omalizumab-igec

CELLTRION, Inc.🇺🇸 United States

FDA Page

Effective Date: Dec 5, 2025
Approval ID: a2075490-d8e7-4c23-8b2e-8f2cd5a67948
Products: 3 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 OMALIZUMAB-IGEC safely and effectively. See full prescribing information for OMALIZUMAB-IGEC. OMALIZUMAB-IGEC injection, for subcutaneous use Initial U.S. Approval: 2025 Omalizumab-igec is biosimilar to XOLAIR (omalizumab)

Quick Stats

Total Products3

Labelers1

Label Sections20

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.