15-07-2025
60 Degrees Pharmaceuticals to submit tafenoquine MUMS designation request to FDA
60 Degrees Pharmaceuticals (SXTP) announced that the company will conduct a gap analysis of its existing data prior to submitting a minor use minor species designation request to the FDA for tafenoquine for the treatment of acute canine babesiosis. The submission will be based on results of three clinical efficacy studies that evaluated Arakoda for canine babesiosis, and existing canine safety data and chemistry manufacturing and controls data for tafenoquine generated through the clinical development of Arakoda for malaria.
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