OMLYCLO

🇺🇸 United States

FDA Page

Effective Date: Aug 6, 2026
Approval ID: dbd8709f-1636-45d9-ba94-5a3bc5f22f84
Products: 0 registered
Version: 6

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OMLYCLO safely and effectively. See full prescribing information for OMLYCLO. OMLYCLO (omalizumab-igec) injection, for subcutaneous use Initial U.S. Approval: 2025 OMLYCLO (omalizumab-igec) is biosimilar to XOLAIR (omalizumab)

Quick Stats

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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.