Category: NDA
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Iterum resubmits NDA for new uUTI antibiotic By Investing.com
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DUBLIN – Iterum Therapeutics plc (NASDAQ:), a clinical-stage pharmaceutical company, announced today the resubmission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the oral antibiotic sulopenem etzadroxil/probenecid, intended for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. This resubmission marks…