Iterum Therapeutics Announces Resubmission Of NDA Filing For Oral Sulopenem

(RTTNews) - Iterum Therapeutics plc (ITRM) announced it has resubmitted New Drug Application to the FDA for sulopenem etzadroxil/probenecid for the treatment of uncomplicated urinary tract infections in adult women. The NDA resubmission includes data from the REASSURE, SURE1, SURE 2 and SURE 3 phase 3 clinical trials.

The company said, provided that the resubmitted NDA addresses all of the deficiencies identified in the complete response letter the company received from the FDA in July 2021, it expects that the FDA will complete review and take action six months from the date the FDA received the resubmitted NDA.

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