60 Degrees says FDA does not object to tafenoquine import plan

60 Degrees Pharmaceuticals (SXTP) announced that the United States Food and Drug Administration does not object to the company’s plan to import Kodatef, or tafenoquine, from Australia as a one-time, preemptive measure against any near-term disruption in the U.S. supply of Arakoda, the U.S. brand name of tafenoquine. “Arakoda is an antimalarial indicated for the prophylaxis of malaria in patients aged 18 years and older in the United States. It is sold under the brand name Kodatef in Australia, where it is indicated for the prevention of malaria in adults 18 years of age and above. The two products are identical in their dosing regimens, mechanisms of action, safety and efficacy profiles, and other clinical features. Kodatef is not approved for use in the U.S. Demand for Arakoda has been steadily growing in recent months as awareness and use of the product has expanded across the U.S. The company is taking the proactive step of importing Kodatef as a demonstration of its long-standing commitment to ensuring that tafenoquine for malaria prophylaxis remains readily available to healthcare providers at all times. The company plans to import a five-month supply of Kodatef while increasing manufacturing output of Arakoda over the long-term. A notice about this information is expected to be posted by FDA on its website,” the company stated.