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# Review Period Determined for Sarepta’s Vyondys 53
- URL: https://www.fdaweb.com/review-period-determined-for-sareptas-vyondys-53/
- Published: 2021-11-02T12:00:00.000Z
- Updated: 2026-09-14T17:21:07.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5150493

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Sarepta Therapeutics’ Vyondys 53 (golodirsen), indicated for treating Duchenne muscular dystrophy. The review period is 1,833 days, which includes 1,474 days that occurred during the testing phase and 359 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-11-01/pdf/2021-23724.pdf?ref=fdaweb.com).