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Cubist Pharmaceuticals Inc announces submission of new drug application for investigational antibiotic ceftolozane/tazobactam

Monday, 21 Apr 2014 08:30am EDT 

Cubist Pharmaceuticals Inc:Submitts New Drug Application (NDA) to U.S. Food and Drug Administration (FDA) for approval of its investigational antibiotic ceftolozane/tazobactam for treatment of Complicated Urinary Tract Infections (cUTI) and Complicated Intra-Abdominal Infections (cIAI).Ceftolozane/tazobactam is antibiotic candidate being developed to treat certain Gram-negative infections.NDA submission is based on positive data from pivotal Phase 3 clinical trials in complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), which met primary endpoints that were agreed upon with the FDA and European Medicines Agency (EMA).Results of secondary analyses were consistent with and supportive of the primary outcomes. 

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1 Aug 2014