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FDA Sets Johnson & Johnson (JNJ)'s TB Drug on Accelerated Path to Approval


9/6/2012 7:34:51 AM

Johnson & Johnson said the U.S. Food and Drug Administration will give a priority review to its experimental treatment for multidrug-resistant tuberculosis. J&J's Janssen Research & Development unit on June 29 applied for approval to market bedaquiline, or TMC207, as part of combination therapy for adults with multidrug-resistant tuberculosis lung infections. Under a priority review, the FDA aims to decide whether to approve drugs within six months of the application's submission, rather than the standard 10 months, because they may offer a major advance or treat a condition with few or no therapies. Bedaquiline would be the first drug specifically for multidrug-resistant tuberculosis, and the first new type of TB drug in more than four decades.

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