Iterum Therapeutics plc has announced the resubmission of its New Drug Application to the Food and Drug Administration (FDA) for the use of sulopenem etzadroxil/probenecid in treating uncomplicated urinary tract infections in adult women. The resubmitted application features data from the REASSURE, SURE1, SURE 2, and SURE 3 phase 3 clinical trials.
Provided that all deficiencies highlighted in the FDA's response letter from July 2021 have been addressed in this resubmission, it is expected that the FDA will complete its review and determines its course of action within six months from the date it received the updated application.
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