Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Status
Approved
Full Title
These highlights do not include all the information needed to use VYONDYS 53 safely and effectively. See full prescribing information for VYONDYS 53. VYONDYS 53 (golodirsen) injection, for intravenous useInitial U.S. Approval: 2019
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.