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# Regulatory Review Period for Danyelza
- URL: https://www.fdaweb.com/regulatory-review-period-for-danyelza/
- Published: 2022-06-29T12:00:00.000Z
- Updated: 2026-09-14T17:50:36.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152195

*Federal Register* notice: FDA has determined for patent term restoration purposes the regulatory review period for Y-mAbs Therapeutics’ Danyelza (naxitamab-gqgk), indicated for use in combination with granulocyte-macrophage colony-stimulating factor for treating pediatric patients one year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. The review period is 3,423 days, of which 3,183 days occurred during the testing phase and 240 days occurred during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-06-29/pdf/2022-13860.pdf?ref=fdaweb.com).