Posted by Michael Wonder on 04 Jun 2024
Iterum Therapeutics receives FDA acceptance of resubmission of NDA for oral sulopenem for the treatment of uncomplicated urinary tract infections
31 May 2024 - Oral sulopenem NDA has been assigned a PDUFA action date of 25 October 2024.
Iterum Therapeutics today announced that the US FDA has acknowledged receipt of the resubmission of the new drug application for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections in adult women.
