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# Innoviva Files NDA for Sul-Dur Antibiotic
- URL: https://www.fdaweb.com/innoviva-files-nda-for-sul-dur-antibiotic/
- Published: 2022-12-01T12:00:00.000Z
- Updated: 2026-09-14T18:08:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153297

FDA has accepted for priority review an Innoviva NDA for intravenous Sul-Dur (sulbactam and durlobactam) for treating infections caused by *Acinetobacter baumannii-calcoaceticus* complex (ABC), including multi-drug resistant and carbapenem-resistant strains. Sulbactam is a β-lactam antibiotic and durlobactam is designed as a broad-spectrum β-lactamase inhibitor, according to the company. The agency has set a user fee review action target date of 5/29/2023.

The submission is based on data from the Phase 3 ATTACK trial that evaluated Sul-Dur versus colistin in patients with infections caused by ABC*.* “In the trial, Sul-Dur demonstrated statistical non-inferiority versus colistin for the primary end point of 28-day all-cause mortality in patients with carbapenem-resistant ABC infections and a significant difference in clinical cure rates,” Innoviva says, adding that Sul-Dur also exhibited a favorable safety profile with statistically significant reduction in nephrotoxicity.