FDA Accepts Combination Antibiotic NDA for Priority Review
Cubist announced that the FDA has accepted its New Drug Application (NDA) for ceftolozane/tazobactam with priority review for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
The NDA 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. Both studies met the specified primary endpoints. Results of the secondary analyses were consistent with and supportive of the primary outcomes. In the clinical trials ceftolozane/tazobactam demonstrated activity against Gram-negative bacteria, including Pseudomonas aeruginosa, extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E. coli), and Klebsiella pneumoniae in patients with complicated infections.
Previously in 2013, ceftolozane/tazobactam was designated as a Qualified Infectious Disease Product (QIDP), for its potential indications of cUTI and cIAI.
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