> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Delays Iterum Antibiotic NDA Review
- URL: https://www.fdaweb.com/fda-delays-iterum-antibiotic-nda-review/
- Published: 2021-04-09T12:00:00.000Z
- Updated: 2026-09-14T16:54:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149082

FDA has told Iterum Therapeutics that it needs more time to review company-submitted “materials” related to the ongoing NDA review for (XXX DELETE sulopenem etzadroxil/probenecid for treating uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen. A previously scheduled 6/2 Antimicrobial Drugs Advisory Committee meeting has also been postponed, according to the company.

In January, the agency accepted the NDA for a priority review and set a 7/25 review action date. The submission is based on data from the SURE-1, SURE-2 and SURE-3 Phase 3 clinical trials, which demonstrated statistical superiority to ciprofloxacin for the primary efficacy endpoint of “clinical and microbiologic response at the test-of-cure visit for patients with a quinolone non-susceptible pathogen,” Iterum says.