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Janssen Research & Development has just submitted a new drug application, or NDA, for its tuberculosis candidate.
Janssen, which is part of the Janssen Pharmaceutical Companies of Johnson & Johnson, is hoping to get their new drug, bedaquiline, approved as treatment for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.
If the FDA approve of bedaquiline, this would be the first TB candidate to do so in more than 40 years. It would also be the first and only treatment to be approved for MDR-TB.
Janssen is hoping for an accelerated approval for the oral TB treatment.