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# Regulatory Review Period for Cablivi
- URL: https://www.fdaweb.com/regulatory-review-period-for-cablivi/
- Published: 2023-05-15T12:00:00.000Z
- Updated: 2026-09-14T18:32:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5154448

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Sanofi’s Cablivi (caplacizumab-yhdp), indicated for treating adult patients with acquired thrombotic thrombocytopenic purpura in combination with plasma exchange and immunosuppressive therapy. The review period for Cablivi is 2,998 days, of which 2,752 days occurred during the testing phase and 246 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-05-15/pdf/2023-10295.pdf?ref=fdaweb.com).