FDA grants Priority Review to ceftolozane/tazobactam NDA

Cubist Pharmaceuticals Inc. (NASDAQ:CBST) said FDA accepted and granted Priority Review to an NDA for ceftolozane/tazobactam to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). The PDUFA date is Dec. 21. The company plans to submit an MAA to EMA next half.

The combination has Qualified Infectious Disease Product (QIDP) designation from FDA for cUTI, cIAI, hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). Cubist has worldwide rights to ceftolozane, a cephalosporin antibiotic, from Astellas Pharma Inc. (Tokyo:4503). Tazobactam is a beta lactamase (LACTB) inhibitor. ...