FDA Grants Accelerated Approval for SIRTURO™ (bedaquiline) as Part of Combination Therapy to Treat Adults with Pulmonary Multi-Drug Resistant Tuberculosis
Posted on December 31, 2012 at 09:05 AM EST
Janssen Therapeutics, Division of Janssen Products, LP, today announced the U.S. Food and Drug Administration (FDA) has granted accelerated approval to SIRTURO™ (bedaquiline) Tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion. "SIRTURO™ was