EMA to review Cubist's ceftolozane/tazobactam

EMA accepted for review an MAA for ceftolozane/tazobactam from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). A decision is expected in 2H15.

In June, FDA granted Priority Review to Cubist's NDA for the IV combination therapy, which comprises the cephalosporin antibiotic ceftolozane (CXA-101) and the beta lactamase inhibitor tazobactam. The PDUFA date is Dec. 21. ...