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# AbbVie Antibiotic OK’d for Abdominal Infections
- URL: https://www.fdaweb.com/abbvie-antibiotic-okd-for-abdominal-infections/
- Published: 2025-02-07T12:00:00.000Z
- Updated: 2026-09-14T14:52:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158626

FDA has approved an AbbVie NDA for Emblaveo (aztreonam and avibactam), a fixed-dose monobactam/β-lactamase inhibitor combination antibiotic. The intravenous antibiotic is approved for combination use with metronidazole in patients 18 years and older who have limited or no alternative options for treating complicated intra-abdominal infections, including those caused by the following susceptible Gram-negative microorganisms: *Escherichia coli*, *Klebsiella pneumoniae*, *Klebsiella oxytoca*, *Enterobacter cloacae complex*, *Citrobacter freundii complex*, and *Serratia marcescens*.

Approval was based on data from the Phase 3 REVISIT clinical trial, a randomized, active-controlled multicenter trial that enrolled 422 patients across 81 locations globally, according to the company. The primary endpoint was clinical cure at the test-of-cure visit in the intent-to-treat (ITT) population, it says, adding that secondary endpoints included 28-day mortality in the ITT population, and safety in patients in the ITT population who received the study drug.