TaiGen Biotechnology files NDA for antibiotic nemonoxacin in Taiwan and China
TaiGen Biotechnology has submitted an New Drug Application for the oral formulation of nemonoxacin, for Infectious Diseases, with the Taiwan Food and Drug Administration and China Food and Drug Administration. The application is based on a pivotal Phase III trial with 532 patients in community-acquired Pneumonia (CAP).
The trial was conducted in both Taiwan and mainland China (441 patients from mainland China and 91 patients from Taiwan) that met all primary and secondary endpoints including non-inferiority to the comparator, levofloxacin. Approval is expected in the first half of 2014.
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