Iterum Therapeutics announces positive pre-NDA meeting with FDA for sulopenem for treatment of uncomplicated urinary tract infections.
Iterum Therapeutics plc , a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings,announced that, based on discussions at a pre-NDA meeting with the FDA, it plans to proceed with an NDA submission for sulopenem etzadroxil/probenecid, a bilayer tablet, for the treatment of uncomplicated urinary tract infections (uUTI) in patients with a quinolone-resistant pathogen.