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Antimicrobial Drugs Advisory Committee

On Thursday, June 6, 2019, the Antimicrobial Drugs Advisory Committee (AMDAC) met to discuss a new drug application (NDA) for pretomanid tablets, submitted by The Global Alliance for TB Drug Development, Inc. (TB Alliance). The proposed use is in combination with bedaquiline and linezolid in adults for the treatment of pulmonary extensively drug resistant tuberculosis (XDR-TB) or treatment-intolerant or nonresponsive multidrug-resistant tuberculosis (TI/NR MDR-TB).

A majority of the committee, 14 of 18 members voted that pretomanid NDA provided substantial evidence of the effectiveness, and sufficient evidence of the safety, for the proposed use to treat adults with XDR-TB or TI/NR MDR-TB.