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Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem drugs
July 28, 2021
Iterum 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 americanpharmaceuticalreview
January 29, 2021
Iterum 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 ...