FDA accepts Actavis' NDA for ceftazidime-avibactam

Ireland-headquartered generic drugs major Actavis (NYSE: ACT) today confirmed that the US Food and Drug Administration has accepted for filing Actavis' New Drug Application for ceftazidime-avibactam.

This is its investigational antibiotic for the treatment of patients with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI), including those caused by multi-drug resistant Gram-negative bacterial pathogens.

As agreed with FDA, ceftazidime-avibactam was submitted as a 505(b)(2) NDA for the treatment of patients with cIAI and cUTI based on the efficacy and safety of ceftazidime, data from Phase II ceftazidime-avibactam studies, robust microbiology and PK/PD analyses. The FDA action date for ceftazidime-avibactam under the Prescription Drug User Fee Act (PDUFA) is expected during Q1 2015.