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# Regulatory Review Period for SK Chemicals’ Afstyla
- URL: https://www.fdaweb.com/regulatory-review-period-for-sk-chemicals-afstyla/
- Published: 2018-10-19T12:00:00.000Z
- Updated: 2026-09-15T00:39:27.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142627

*Federal Register* notice: FDA has determined for patent extension-related purposes the regulatory review period for SK Chemicals’ Afstyla (antihemophilic factor (recombinant), single chain), indicated for use in children and adults with hemophilia A (congenital Factor VIII deficiency). The regulatory review period is 1,734 days, including 1,371 days that occurred during the testing phase and 363 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-18/pdf/2018-22696.pdf?ref=fdaweb.com).