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# Regulatory Review Period for Ztalmy
- URL: https://www.fdaweb.com/regulatory-review-period-for-ztalmy/
- Published: 2024-09-11T12:00:00.000Z
- Updated: 2026-09-14T14:40:59.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157752

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Marinus Pharmaceuticals’ Ztalmy (ganaxolone), indicated for treating seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients two years of age and older. The regulatory review period is 10,382 days, of which 10,065 days occurred during the testing phase and 317 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-09-11/pdf/2024-20549.pdf?ref=fdaweb.com).