TaiGen Biotechnology Announces Submission of New Drug Application for Taigexyn Intravenous Formulation to the … – PR Newswire (press release)

TAIPEI, Taiwan, May 30, 2017 /PRNewswire/ --TaiGen Biotechnology Company, Limited ("TaiGen") today announced that it has submitted a New Drug Application (NDA) for the intravenous formulation of Taigexyn (Nemonoxacin) to the China Food and Drug Administration (CFDA). Taigexyn is a novel non-fluorinated quinolone antibiotic.The NDA submission is supported by a pivotal Phase 3 trial comparing intravenous formulations of Taigexyn 500 mg to levofloxacin 500 mg in 518 patients with moderate to severe community-acquired pneumonia. The clinical success rates were 91.8% for Taigexyn vs. 85.7% for levofloxacin and Taigexyn was shown to be non-inferior to levofloxacin meeting the primary endpoint of the pivotal trial.

About Taigexyn Taigexyn is a novel broad spectrum antibiotic with excellent efficacy against drug-resistant bacteria available in both oral and intravenous formulations. The oral formulation is already approved for marketing and launched in Taiwan and mainland China. In addition, Taigexyn is also partnered in Russia, Commonwealth Independent States, Turkey, Mexico, Brazil and the Latin American territory for a total 32 countries worldwide.

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TaiGen Biotechnology Announces Submission of New Drug Application for Taigexyn Intravenous Formulation to the ... - PR Newswire (press release)