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Antimicrobial Drugs Advisory Committee

On Thursday, July 26, 2018 the Antimicrobial Drugs Advisory Committee (AMDAC) discussed a new drug application (NDA) for tafenoquine tablets, sponsored by 60 Degrees Pharmaceuticals, LLC (60 Degrees), for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing.

A majority of the Committee, 11 of 13 members, voted that 60 Degrees has provided substantial evidence of the effectiveness of tafenoquine for the proposed use.

A slightly lesser majority of the Committee, 9 of 13 members, voted that 60 Degrees has provided adequate evidence of the safety of tafenoquine for the proposed use.