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Concerning Bedaquiline & Tuberculosis (TB), the U.S. FDA granted accelerated approval to bedaquiline on 28 December 2012 as part of combination therapy for adults with pulmonary multidrug‑resistant Tuberculosis (TB) (MDR‑TB) (1, 2). The indication is for use in combination with other appropriate anti‑TB drugs; it is not approved as monotherapy and is focused on drug‑resistant, not drug‑susceptible, TB (2, 3).
The European Medicines Agency granted conditional marketing authorisation for bedaquiline in 2014 for adults with pulmonary MDR‑TB (4). As in the U.S., bedaquiline is authorise…