FDA accepts ceftazidime/avibactam NDA

Actavis plc (NYSE:ACT) said FDA accepted for review an NDA for ceftazidime/ avibactam ( CAZ-104) to treat complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs). The PDUFA date is in 1Q15, but the company did not provide a specific date. Actavis submitted the application under section 505(b)(2) of the Food, Drug and Cosmetic Act, which allows sponsors to reference data on safety and efficacy from the scientific literature or from previously approved products.

Actavis gained rights to ceftazidime/avibactam through its July acquisition of Forest Laboratories Inc. The product is a combination of ceftazidime, a third-generation cephalosporin, and avibactam, a broad-spectrum beta lactamase (LACTB) inhibitor. ...