Medication Monitor

Generic Name (Trade Name—Company)
June 13, 2019


(Zerbaxa—Merck & Co.)
FDA approves new treatment for hospital-acquired and ventilator-associated bacterial pneumonia

FDA approved a new indication for ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) in patients 18 years and older. FDA initially approved ceftolozane/tazobactam in 2014 to treat complicated intra-abdominal infections and for complicated urinary tract infections.

HABP/VABP occur in patients in hospitals or other health care facilities and can be caused by a variety of bacteria. According to CDC data, HABP and VABP are currently the second most common type of hospital-acquired infection in the United States and are a significant issue in patients in the intensive care unit (ICU).

Safety and efficacy of ceftolozane/tazobactam for treatment of HABP/VABP, administered via injection, was demonstrated in a multinational, double-blind study that compared ceftolozane/tazobactam to another antibacterial drug in 726 adult patients hospitalized with HABP/VABP. The study showed that mortality and cure rates were similar between ceftolozane/tazobactam and the comparator treatment.

In the clinical trials, the most common adverse reactions were elevated liver enzyme levels, renal impairment or failure, and diarrhea.

Ceftolozane/tazobactam should not be used in patients with known serious hypersensitivity to its components, as well as hypersensitivity to piperacillin/tazobactam or other members of the beta-lactam class of antibacterial drugs.

The FDA granted the approval of Zerbaxa for the treatment of HABP/VABP to Merck & Co., Inc.