Indication: Bedaquiline has been approved for adults 18 years of age and older with multidrug-resistant strains of pulmonary tuberculosis (MDR-TB). The medication is intended to be part of combination therapy when an effective alternative treatment is not available. This indication was based on an analysis of time to sputum culture conversion from two controlled phase 2 trials. The safety and efficacy of bedaquiline in treating latent infection caused by Mycobacterium tuberculosis have not been established.
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