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August 22, 2014
07:31 EDTCBSTCubist annouces EMA acceptance of ceftolozane, tazobactam MAA
Cubist announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application for its investigational antibiotic ceftolozane, tazobactam. Cubist is seeking approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections, with a decision from the European Commission expected during 1H15. The MAA submission is based on positive data from two pivotal Phase 3 clinical trials of ceftolozane, tazobactam in complicated urinary tract infections and complicated intra-abdominal infections. These studies met both the EMA and U.S. Food and Drug Administration specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes.
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