Ceftolozane/tazobactam regulatory update

Cubist submitted an NDA to FDA for ceftolozane/tazobactam to treat complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). The company plans to submit an MAA to EMA next half. Cubist is also planning to start Phase III testing of ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP), but declined to provide a specific timeline. The product has Qualified Infectious Disease Product (QIDP) designation from FDA for all 4 indications. ...