60 Degrees Pharmaceuticals Secures FDA Nod to Import KODATEF Amid Rising ARAKODA Demand

In a proactive move to ensure an uninterrupted supply of tafenoquine for malaria prevention, 60 Degrees Pharmaceuticals (NASDAQ: SXTP; SXTPW) announced that the U.S. FDA has no objections to the company’s plan to import KODATEF® from Australia. This one-time measure aims to safeguard against potential short-term disruptions in the availability of ARAKODA®, the U.S.-approved version of the drug. Both products share identical formulations, mechanisms of action, and efficacy, though KODATEF is not currently approved for U.S. use.

With demand for ARAKODA steadily rising, 60 Degrees Pharmaceuticals is taking decisive steps to maintain supply continuity. The company will import a five-month supply of KODATEF while ramping up ARAKODA production to meet growing U.S. demand. This initiative underscores the company’s commitment to ensuring healthcare providers have consistent access to tafenoquine, reinforcing its role in malaria prophylaxis.