Xenleta

🇺🇸 United States

FDA Page

Effective Date: Jul 22, 2026
Approval ID: eb972ea8-7502-422e-84bb-66cb8e93ca06
Products: 0 registered
Version: 1

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use XENLETA safely and effectively. See full prescribing information for XENLETA. XENLETA (lefamulin) injection, for intravenous use XENLETA (lefamulin) tablets, for oral use Initial U.S. Approval: 2019

Quick Stats

Total Products0

Labelers0

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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.