Drug news
FDA Advisory Committee recommends bedaquiline (Janssen)for treatment of Tuberculosis
Janssen Research & Development, LLC (Janssen) has announced that the Anti-Infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA), in a unanimous vote (18-0), agreed that the efficacy findings for investigational bedaquiline support the proposed indication for the treatment of pulmonary multi-drug resistant Tuberculosis (MDR-TB) as part of combination therapy in adults. The committee agreed in a vote of 11-7 that the safety findings supported the proposed indication.
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