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# Priority Review Voucher for Vyondys 53 Approval
- URL: https://www.fdaweb.com/priority-review-voucher-for-vyondys-53-approval/
- Published: 2020-01-24T12:00:00.000Z
- Updated: 2026-09-14T15:59:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145918

*Federal Register* notice: FDA has issued a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys 53 (golodirsen) for treating Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-01-23/pdf/2020-01059.pdf?ref=fdaweb.com).