Cubist NDA gets Priority Review

The FDA accepts Cubist Pharmaceuticals' (CBST) NDA for its investigational antibiotic ceftolozane/tazobactam with Priority Review. The company seeks approval for the combination drug as a treatment for complicated urinary tract infections and complicated intra-abdominal infections. The PDUFA date is December 21, 2014.

Last year, the agency designated ceftotozane/tazobactam as a Qualified Infectious Disease Product (QIDP) according to the Generating Antibiotic Incentives Now (GAIN) Act. QIDP designation provides incentives for the development of new antibiotics including Fast Track status, Priority Review and a five-year extension of Hatch-Waxman exclusivity post regulatory clearance.

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