September 9, 2024 Meeting of the Antimicrobial Drugs Advisory Committee (AMDAC)

The Committee will discuss new drug application (NDA) 213972, for oral sulopenem etzadroxil/probenecid tablets consisting of 500 mg sulopenem etzadroxil and 500 mg probenecid, submitted by Iterum Therapeutics US Limited, for the proposed indication of treatment of uncomplicated urinary tract infections (uUTIs) caused by designated susceptible bacteria in adult women 18 years of age and older.