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# FDA ‘Complete Response’ on Iterum NDA
- URL: https://www.fdaweb.com/fda-complete-response-on-iterum-nda/
- Published: 2021-07-26T12:00:00.000Z
- Updated: 2026-09-14T17:07:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149781

FDA has issued Iterum Therapeutics a complete response letter on its NDA for sulopenem etzadroxil/probenecid, indicated for treating multi-drug resistant infections, including fast-growing quinolone non-susceptible pathogens. The company says the agency letter “acknowledged that the Phase 3 SURE-1 clinical trial demonstrated statistical significance in difference in overall response rate of oral sulopenem compared to ciprofloxacin in the ciprofloxacin-resistant population. However, the FDA determined that additional data are necessary to support approval for the treatment of adult women with uncomplicated urinary tract infections caused by designated susceptible microorganisms proven or strongly suspected to be non-susceptible to a quinolone.”  
  
The agency recommended at least one additional adequate and well-controlled clinical trial, potentially using a different comparator drug, Iterum says. “Additionally, the FDA recommended that Iterum conduct further nonclinical investigation to determine the optimal dosing regimen, although the FDA stated that this recommendation does not raise an approvability issue,” it says.