Iterum Therapeutics disclosed in a US Securities and Exchange Commission (SEC) filing that the FDA needs more time to review materials that have been provided by the company to support its marketing application for sulopenem etzadroxil/probenecid.
Iterum is seeking to have the treatment approved for uncomplicated urinary tract infections in patients with a quinolone non-susceptible pathogen.
As a result of the additional review time, a previously scheduled FDA advisory committee meeting to discuss the new drug application on June 2 has been postponed as well.
In the SEC filing, Iterum said a new date for the advisory panel has not yet been confirmed and the company "continues to work closely with the FDA to facilitate its review."
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