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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 Submits NDA for Oral Sulopenem americanpharmaceuticalreview
December 16, 2020
Iterum 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 ...