Posted by Michael Wonder on 26 Jul 2021
Iterum Therapeutics receives complete response letter from U.S. FDA for oral sulopenem
26 July 2021 - Iterum Therapeutics today announced that it received a complete response letter from the U.S. FDA for its new drug application for sulopenem etzadroxil/probenecid (oral sulopenem) on 23 July 2021.
The complete response letter provided that the FDA has completed its review of the new drug application and has determined that it cannot approve the new drug application in its present form.
