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Cubist Pharmaceuticals Inc announces acceptance of Ceftolozane/Tazobactam new drug application with priority review

Thursday, 19 Jun 2014 04:30pm EDT 

Cubist Pharmaceuticals Inc:Says U.S. Food and Drug Administration (FDA) accepted company's New Drug Application (NDA) for investigational antibiotic ceftolozane/tazobactam with Priority Review.FDA has assigned Prescription Drug User Fee Act (PDUFA) action date of Dec. 21, 2014.Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections. 

Company Quote

2.75 +4.14%
22 Oct 2014