FDA needs more time to review filing for Iterum's sulopenem etzadroxil/probenecid - (SEC via NewsPoints Desk)

  • 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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