Iterum (ITRM) says FDA needs more time to review materials in support of NDA for sulopenem etzadroxil/probenecid

April 9, 2021 8:18 AM EDT
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Iterum Therapeutics Plc (NASDAQ: ITRM) disclosed:

On April 8, 2021, Iterum Therapeutics plc (the “Company”) received notice from the U.S. Food and Drug Administration (“FDA”) that it needs more time to review materials that have been provided by the Company in support of the Company’s new drug application (“NDA”) for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen and therefore, the previously scheduled FDA Antimicrobial Drugs Advisory Committee (the “Panel”) on June 2, 2021 has been postponed. A new date for the Panel review of the Company’s NDA has not yet been confirmed and the Company continues to work closely with the FDA to facilitate its review.

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