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# Regulatory Review Period Determined for Besponsa
- URL: https://www.fdaweb.com/regulatory-review-period-determined-for-besponsa/
- Published: 2018-10-23T12:00:00.000Z
- Updated: 2026-09-15T00:40:05.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5142645

*Federal Register* notice: FDA has determined for patent extension-related purposes the regulatory review period for Wyeth’s Besponsa (inotuzumab ozogamicin), indicated for treating adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. The regulatory review period was determined to be 5,298 days, which included 5,057 days that occurred during the testing phase and 241 days during the approval phase. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-10-22/pdf/2018-22958.pdf?ref=fdaweb.com).