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Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem
July 28, 2021Iterum Therapeutics plc (Nasdaq: ITRM) today announced that it received a Complete Response Letter (CRL) from the FDA for its NDA for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021. -
Iterum Therapeutics Submits NDA for Oral Sulopenem
December 16, 2020Iterum Therapeutics has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a ...
Pharma Sources Insight January 2025
