Iterum Therapeutics has secured FDA approval for its Orlynvah (sulopenem etzadroxil and probenecid) to treat uncomplicated urinary tract infections (uUTIs) in adult women. This is the first FDA-approved product for Iterum and offers a new treatment option for women with limited alternative oral antibacterial treatment options. The approval was based on two successful Phase 3 clinical trials demonstrating Orlynvah’s safety and efficacy compared to existing treatments.