Iterum: FDA Accepts Resubmission Of NDA For Oral Sulopenem

(RTTNews) - Iterum Therapeutics (ITRM) announced the FDA has acknowledged receipt of the resubmission of the New Drug Application for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women. The FDA has deemed the company's NDA resubmission to be a Class II complete response. The resubmission includes additional evidence from the REASSURE clinical trial, conducted under Special Protocol Assessment agreement from the FDA. The FDA has assigned a PDUFA action date of October 25, 2024.

Corey Fishman, Chief Executive Officer, said: "We look forward to continuing to work with the FDA during its review."

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