Ceftolozane/tazobactam regulatory update

FDA granted Qualified Infectious Disease Product (QIDP) designation for ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) and complicated urinary tract infection (cUTI) and Fast Track designation to treat complicated intra-abdominal infections (cIAIs). The product already has QIDP designation for cIAI (see BioCentury, Dec. 17, 2012). Under the Generating Antibiotic Incentives Now (GAIN) program, ceftolozane/tazobactam is eligible for an additional 5 years of market exclusivity if it is approved and for Priority Review and Fast Track designation. GAIN, which creates incentives to develop new drugs against pathogens with "the potential to pose a serious threat to public health," is part of the FDA Safety and Innovation Act signed into law last year. ...