Iterum Therapeutics Says FDA Determines To Take NDA For Sulopenem To Advisory Committee
(RTTNews) - Pharmaceutical company Iterum Therapeutics plc (ITRM) announced Friday that the U.S. Food and Drug Administration (FDA) has determined that the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women will be taken to Advisory Committee.
The FDA in its communication highlighted that the purpose of the Advisory Committee was to discuss a) antimicrobial stewardship issues raised by potential approval and subsequent use of what would be the first oral penem in the U.S.; and b) the most appropriate target patient population(s) for treatment of uUTI with sulopenem etzadroxil/probenecid.
The proposed date for the Advisory Committee meeting is September 9, 2024.
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