Iterum Therapeutics Announces U.S. Commercial Launch Of ORLYNVAH Oral Tablets

Author: Benzinga Newsdesk | August 20, 2025 07:02am

Iterum Therapeutics plc (NASDAQ:ITRM), a company focused on delivering next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced the U.S. commercial launch of ORLYNVAH™ (sulopenem etzadroxil and probenecid) oral tablets. The Food and Drug Administration (FDA) approved ORLYNVAH™ for adult women with uncomplicated urinary tract infections (uUTIs) caused by Escherichia coli, Klebsiella pneumoniae or Proteus mirabilis with limited or no alternative oral antibacterial options in October 2024. ORLYNVAH™ is the first oral penem antibiotic commercially available in the U.S. and the first new branded product to be introduced in the U.S. for uUTI in more than 25 years – offering a critical option for patients and physicians facing a shrinking arsenal of effective oral therapies.

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