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US FDA Grants Exclusivity/Fast Track Designations to TaiGen Antibiotic

publication date: Dec 23, 2013
TaiGen Biotech, a Taiwan-Beijing company, said its lead antibiotic drug, nemonoxacin (Taigexyn®), was granted two important designations by the US FDA: Qualified Infectious Disease Product and Fast Track. The designations add a five-year extension to the antibiotic’s exclusivity, priority review and fast track status. In May, TaiGen submitted nemonoxacin for New Drug Approval in Taiwan and China as a treatment for community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections. More details....

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