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# Regulatory Review Periods for Erleada and Xospata
- URL: https://www.fdaweb.com/regulatory-review-periods-for-erleada-and-xospata/
- Published: 2023-02-09T12:00:00.000Z
- Updated: 2026-09-14T18:15:18.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5153747

*Federal Register* notice: FDA has determined for patent term extension purposes the regulatory review periods for two drug products. The first is for Janssen’s Erleada (apalutamide), indicated for treating patients with non-metastatic castration-resistant prostate cancer. The regulatory review period is 2,795 days, of which 2,667 days occurred during the testing phase and 128 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-09/pdf/2023-02743.pdf?ref=fdaweb.com).

The other determination is for Astellas Pharma’s Xospata (gilteritinib), indicated for treating adult patients who have relapsed or refractory acute myeloid leukemia with a FLT3 mutation as detected by an FDA-approved test. The regulatory review period is 2,002 days, of which 1,757 days occurred during the testing phase and 245 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2023-02-09/pdf/2023-02745.pdf?ref=fdaweb.com).