Anti-Infective Drugs Advisory Committee

Anti-Infective Drugs Advisory Committee Committee Meeting November 28, 2012 8:00 a.m. to 5:00 p.m. (Day 1 of 2) Agenda: On November 28, 2012, the committee will discuss the safety and effectiveness of new drug application (NDA) 204384, bedaquiline tablets, submitted by Janssen Therapeutics, Division of Janssen Products, LP. The proposed indication (use) for this product is for the treatment of patients with multi-drug resistant pulmonary tuberculosis.