Ohtuvayre

Verona Pharma, Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 23, 2026
Approval ID: e6433c98-41a0-4f99-8f7f-d0e9db6e3f40
Products: 1 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 OHTUVAYRE™ safely and effectively. See full prescribing information for OHTUVAYRE. OHTUVAYRE (ensifentrine) inhalation suspension, for oral inhalation use Initial U.S. Approval: 2024

Quick Stats

Total Products1

Labelers3

Label Sections36

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.