NEWS
Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections
Iterum Therapeutics announced that the FDA has accepted the resubmission of its New Drug Application (NDA) for oral sulopenem, aimed at treating uncomplicated urinary tract infections (uUTIs) in adult women. The FDA has assigned a PDUFA action date of October 25, 2024. This milestone follows the REASSURE clinical trial, which showed that oral sulopenem was non-inferior to Augmentin® and even demonstrated statistically significant superiority in overall success rate. The FDA's acceptance marks a critical step towards potentially providing a new treatment option for uUTIs, addressing a significant unmet medical need.
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