OTARMENI

Regeneron Pharmaceuticals, Inc.🇺🇸 United States

FDA Page

Effective Date: Apr 27, 2026
Approval ID: a7a5e936-ab4a-4609-ac10-96efedc89035
Products: 1 registered
Version: 5

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use OTARMENI safely and effectively. See full prescribing information for OTARMENI. OTARMENI™ (lunsotogene parvec-cwha) suspension, for intracochlear infusion Initial U.S. Approval: 2026

Quick Stats

Total Products1

Labelers1

Label Sections15

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.