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              Janssen Pharmaceutical

              • Development Update

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              UNITED STATES United States

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              Chemspec USA 2020

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              U.S. FDA Approves New Pediatric Formulation of SIRTURO® (bedaquiline) as Part of Combination Therapy

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              Lead Product(s): Bedaquiline

              Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 27, 2020

              Details:

              SIRTURO® is now indicated for use as part of combination therapy in the treatment of adult and pediatric patients (5 years and older and weighing at least 15 kg) with pulmonary multidrug-resistant tuberculosis (MDR‑TB).

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