Ceftolozane/tazobactam regulatory update

FDA granted Fast Track designation to ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) and complicated urinary tract infection (cUTI). The product already has Fast Track designation to treat complicated intra-abdominal infections (cIAIs) and Qualified Infectious Disease Product (QIDP) designation for all 4 indications (see BioCentury, Dec. 17, 2012 & March 11, 2013). The product is in Phase III testing to treat cIAI and cUTI caused by Gram-negative bacteria and multi-drug resistant Pseudomonas aeruginosa. Cubist plans to start Phase III testing to treat VABP by mid-year. The product is a combination of ceftolozane (CXA-101), a cephalosporin antibiotic, and the beta lactamase inhibitor tazobactam. ...