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Iterum Therapeutics announces positive pre-NDA meeting with FDA for sulopenem for treatment of uncomplicated urinary tract infections.

Read time: 1 mins

Published:4th Oct 2020

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.

Condition: Infectious Diseases/UTI

Type: drug

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