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Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections
Iterum Therapeutics (Nasdaq: ITRM) has received FDA approval for ORLYNVAH™, the first oral penem approved in the U.S. for treating uncomplicated urinary tract infections (uUTIs). The drug is specifically approved for adult women with or no alternative oral antibacterial treatment options against designated microorganisms. The approval is based on two Phase 3 clinical trials, SURE 1 and REASSURE, which demonstrated superiority to ciprofloxacin in fluoroquinolone resistant infections and statistical superiority to Augmentin™ in the susceptible population, respectively. ORLYNVAH™ represents the second FDA-approved treat
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