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# Merck’s Recarbrio OK’d for Severe Infections
- URL: https://www.fdaweb.com/mercks-recarbrio-okd-for-severe-infections/
- Published: 2019-07-17T12:00:00.000Z
- Updated: 2026-09-15T01:38:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144553

FDA has approved Merck’s Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs for treating a patient’s infection,” an [agency release](https://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-complicated-urinary-tract-and-complicated-intra-abdominal-infections?ref=fdaweb.com) says. 

Recarbrio is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic, and relebactam, a new beta-lactamase inhibitor. Approval was based on data showing efficacy and safety of imipenem-cilastatin for treating cUTI and cIAI. “The contribution of relebactam to Recarbrio was assessed based on data from *in vitro* studies and animal models of infection,” FDA says. “The safety of Recarbrio, administered via injection, was studied in two trials, one each for cUTI and cIAI. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of Recarbrio. The cIAI trial included 347 patients with 117 treated with the proposed dose of Recarbrio.”