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# Regulatory Review Period for Ogsiveo
- URL: https://www.fdaweb.com/regulatory-review-period-for-ogsiveo/
- Published: 2024-09-26T12:00:00.000Z
- Updated: 2026-09-14T14:42:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157862

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for SpringWorks Therapeutics’ Ogsiveo (nirogacestat hydrobromide), indicated for adult patients with progressing desmoid tumors who require systemic treatment. The regulatory review period is 5,425 days, of which 5,089 days occurred during the testing phase and 336 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-26/pdf/2024-22105.pdf?ref=fdaweb.com).