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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 Announces NDA for Oral Sulopenem
January 29, 2021Iterum Therapeutics announced the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in ...
Pharma Sources Insight January 2025
