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# Merck Wins New Indication for Zerbaxa
- URL: https://www.fdaweb.com/merck-wins-new-indication-for-zerbaxa/
- Published: 2019-06-03T12:00:00.000Z
- Updated: 2026-09-15T01:30:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144247

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

Zerbaxa’s new indication was supported by data from a multinational, double-blind study that compared Zerbaxa to another antibacterial drug in 726 adult patients hospitalized with HABP/VABP, an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-hospital-acquired-and-ventilator-associated-bacterial-pneumonia?ref=fdaweb.com) says. The study showed that mortality and cure rates were similar between Zerbaxa and the comparator treatment.

The most common adverse reactions observed in study and associated with Zerbaxa were elevated liver enzyme levels, renal impairment or failure, and diarrhea.