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# Regulatory Review Period for Sarepta’s Duchenne Drug
- URL: https://www.fdaweb.com/regulatory-review-period-for-sareptas-duchenne-drug/
- Published: 2019-02-11T12:00:00.000Z
- Updated: 2026-09-15T01:02:48.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143343

*Federal Register* notice: FDA has determined that the regulatory review period for Sarepta’s Duchenne drug Exondys 51 (eteplirsen) is 2,280 days, including 1,828 days that occurred during the testing phase and 452 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-02-11/pdf/2019-01851.pdf?ref=fdaweb.com).