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# Regulatory Review Period for Lumoxiti
- URL: https://www.fdaweb.com/regulatory-review-period-for-lumoxiti/
- Published: 2020-09-01T12:00:00.000Z
- Updated: 2026-09-14T16:27:11.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5147553

*Federal Register* notice: FDA has determined for patent extension purposes the regulatory review period for Innate Pharma’s Lumoxiti (moxetumomab pasudotox-tdfk), indicated for treating adult patients with relapsed or refractory hairy cell leukemia who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The regulatory review period is 4,320 days, which includes 4,092 days that occurred during the testing phase and 228 days during the approval phase. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-09-01/pdf/2020-19214.pdf?ref=fdaweb.com).