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# FDA Accepts Medac’s Treosulfan NDA Resubmission
- URL: https://www.fdaweb.com/fda-accepts-medacs-treosulfan-nda-resubmission/
- Published: 2024-06-06T12:00:00.000Z
- Updated: 2026-09-14T14:32:42.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157127

Medexus Pharmaceuticals says FDA has accepted for review its Medac licensor’s resubmitted NDA for treosulfan, indicated for combination use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation. Medac’s resubmission provided additional information previously requested by FDA relating to the pivotal Phase 3 clinical trial of treosulfan conducted by Medac, according to Medexus. The company launched treosulfan in Canada under the brand name Trecondyv 9/2021\. The agency has set a user fee review action target date of 10/30.