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# Trisenox Not Withdrawn Over Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/trisenox-not-withdrawn-over-safety-efficacy-fda/
- Published: 2019-04-18T12:00:00.000Z
- Updated: 2026-09-15T01:21:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5143899

*Federal Register* notice: FDA has determined that Cephalon’s Trisenox (arsenic trioxide) injection, 1mg/mL, was not withdrawn for safety or effectiveness reasons. The determination allows FDA to continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. Trisenox is indicated in combination with tretinoin for treating adults with newly diagnosed low-risk acute promyelocytic leukemia (APL) whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2019-04-18/pdf/2019-07828.pdf?ref=fdaweb.com).