Actavis Announces FDA Acceptance of the NDA Filing for Ceftazidime-Avibactam, a Qualified Infectious Disease Product - Potential Treatment For Patients With Complicated Urinary Tract Infections(cUTI) and Complicated Intra-Abdominal Infections (cIAI) - Actavis plc 19 hours ago DUBLIN, Sept. 5, 2014 /PRNewswire/ -- Actavis plc (ACT) today confirmed that the U.S. Food and Drug Administration (FDA) has accepted for filing Actavis' application for ceftazidime-avibactam, 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. Logo - http://photos.prnewswire.com/prnh/20130124/NY47381LOGO 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. On August 19, 2014, Actavis announced positive topline results from the single pooled dataset of RECLAIM-1 and -2, pivotal Phase III studies evaluating the potential for ceftazidime-avibactam as a treatment for adult patients with cIAI. The company intends to submit the results of the Phase III studies to the FDA as a supplemental New Drug Application (sNDA).
