WASHINGTON, July 17 (Xinhua) -- The U.S. Food and Drug Administration (FDA) Wednesday approved Recarbrio, an antibacterial drug product, to treat adults with urinary and intra-abdominal infections.
Recarbrio was approved to be used for situations when there are limited or no alternative antibacterial drugs for treating a patient with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).
It is a three-drug combination injection containing imipenem-cilastatin, a previously FDA-approved antibiotic duo, and relebactam, a new beta-lactamase inhibitor, according to the FDA.
The contribution of relebactam to Recarbrio was assessed based on data from in vitro studies and animal models of infection. The cUTI trial included 298 adult patients with 99 treated with the proposed dose of Recarbrio and the cIAI trial included 347 patients with 117 treated with the proposed dose of Recarbrio.
The most common adverse reactions observed in patients treated with Recarbrio included nausea, diarrhea, headache, fever and increased liver enzymes.