ELEVIDYS

Sarepta Therapeutics, Inc.🇺🇸 United States

FDA Page

Effective Date: Aug 12, 2026
Approval ID: 3525abcd-fbd2-46c5-9706-cffdf2e8a361
Products: 20 registered
Version: 12

Regulatory Information

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Status

Approved

Full Title

These highlights do not include all the information needed to use ELEVIDYS safely and effectively. See full prescribing information for ELEVIDYS. ELEVIDYS (delandistrogene moxeparvovec-rokl) suspension, for intravenous infusion Initial U.S. Approval: 2023

Quick Stats

Total Products20

Labelers2

Label Sections101

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.