J&J Seeks Approval Of TB Drug | Chemical & Engineering News
Volume 90 Issue 28 | p. 15 | Concentrates
Issue Date: July 9, 2012

J&J Seeks Approval Of TB Drug

Department: Business
Keywords: neglected diseases, pharmaceuticals, NDAs

Janssen Research & Development, an arm of Johnson & Johnson, has filed a New Drug Application for bedaquiline, an antibiotic to be used in a combination regimen to treat multi-drug-resistant tuberculosis (MDR-TB). If approved, the diarylquinoline will be the first TB compound with a new mechanism of action in more than 40 years. Approval would also bring J&J a priority review voucher, a certificate that companies developing drugs against neglected diseases can use to speed up FDA review of another drug.

 
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ISSN 0009-2347
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