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# Regulatory Review Period Determined for Byfavo
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-byfavo/
- Published: 2023-01-24T12:00:00.000Z
- Updated: 2026-09-14T18:12:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153610

*Federal Register* notice: FDA has determined for patent term extension purposes the regulatory review period for Acacia Pharma’s Byfavo (remimazolam), indicated for inducing and maintaining procedural sedation in adults undergoing procedures lasting 30 minutes or less. The regulatory review period is 4,482 days, of which 3,931 days occurred during the testing phase and 551 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-01-24/pdf/2023-01220.pdf?ref=fdaweb.com).