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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
Medication labelWhy this: Advisory · dailymed-prescription
VYONDYS 53 is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VYONDYS 53 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials.
- generic_name
- golodirsen
- product_names
- golodirsen
- ndc
- 60923-465, 60923-465-02
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en