The FDA has accepted a new drug application for Cubist Pharmaceuticals Inc’s combination antibiotic ceftolozane/tazobactam with priority review, according to the company.
The new drug application is based on results from two phase 3 clinical trials of ceftolozane/tazobactam, which demonstrated activity against several gram-negative pathogens causing UTIs and intra-abdominal infections in adult patients. These included Pseudomonas aeruginosa, extended-spectrum beta-lactamase–producing Escherichia coli and Klebsiella pneumoniae.
Under the Generating Antibiotic Incentives Now (GAIN) Act, the FDA designated the antibiotic as a qualified infectious disease product (QIDP) in 2013, making it eligible for fast track status and priority review. QIDP status also gives Cubist a 5-year extension of product exclusivity if the drug is ultimately approved by the FDA.
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