Actavis Announces FDA Acceptance Of NDA Filing For Ceftazidime-Avibactam

(RTTNews) - Actavis plc (ACT) confirmed that the U.S. Food and Drug Administration or FDA has accepted for filing Actavis' application for ceftazidime-avibactam, its investigational antibiotic for the treatment of patients with Complicated Urinary Tract Infections or cUTI and Complicated Intra-Abdominal Infections or cIAI, including those caused by multi-drug resistant Gram-negative bacterial pathogens.

Ceftazidime-avibactam was submitted as a 505(b)(2) NDA to treat 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 or PDUFA is expected in the first quarter of 2015.

On August 19, Actavis reported positive topline results from the single pooled dataset of RECLAIM-1 and -2, pivotal Phase III trials, assessing the potential for ceftazidime-avibactam as a treatment for adult patients with cIAI. The company plans to submit the results of the Phase III studies to the FDA as a supplemental New Drug Application or sNDA.