Core Viewpoint - 60 Degrees Pharmaceuticals, Inc. has received FDA approval to import KODATEF (tafenoquine) from Australia as a precautionary measure to ensure the availability of ARAKODA (tafenoquine) in the U.S. market [1][3] Group 1: Product Information - ARAKODA is an antimalarial drug approved for malaria prophylaxis in patients aged 18 and older in the U.S., while KODATEF is its equivalent in Australia [2][5] - Both ARAKODA and KODATEF share identical dosing regimens, mechanisms of action, safety and efficacy profiles [2][5] - Tafenoquine has a long terminal half-life of approximately 16 days, allowing for less frequent dosing [5] Group 2: Market Demand and Supply Strategy - Demand for ARAKODA has been increasing in the U.S. due to heightened awareness and usage [3] - The company plans to import a five-month supply of KODATEF while also increasing the manufacturing output of ARAKODA in the long term [3] Group 3: Company Background - 60 Degrees Pharmaceuticals, Inc. was founded in 2010 and focuses on developing medicines for infectious diseases [16] - The company achieved FDA approval for ARAKODA in 2018, with both ARAKODA and KODATEF launched commercially in 2019 [5][16]
Sixty Degrees Pharmaceuticals to Ensure Continuity of Tafenoquine Supply in U.S. by Importing Limited Quantity of KODATEF®