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Antimicrobial Drugs Advisory Committee

On Thursday, July 12, 2018, the Antimicrobial Drugs Advisory Committee (AMDAC) reviewed a new drug application (NDA) for tafenoquine (TQ) tablets, sponsored by GlaxoSmithKline Intellectual Property Development Ltd. (GSK), for the proposed indication of the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.

The Committee voted unanimously (13 of 13 members) that GSK has provided substantial evidence of the effectiveness of tafenoquine for the radical cure (prevention of relapse) of P. vivax malaria in patients 16 years of age and older. T

A majority of the Committee, 12 of 13 members, voted that GSK has provided adequate evidence of the safety of tafenoquine for the proposed use.