By IDSE News Staff
The FDA approved sulopenem etzadroxil (Orlynvah, Iterum Therapeutics) to treat uncomplicated urinary tract infections (uUTIs) caused by specific bacteria in adult women with limited or no alternative oral antibacterial treatment options.
The FDA approval of sulopenem etzadroxil was based on a clinical development program supported by a robust data package, including two pivotal, phase 3 clinical trials (known as SURE 1 and REASSURE) that evaluated the safety and efficacy