After prior rejection, Iterum nabs long-sought FDA nod for oral UTI drug Orlynvah
Fierce Pharma
OCTOBER 25, 2024
Despite recent concerns from the FDA about potential off-label use and antimicrobial resistance, Dublin-based Iterum Therapeutics has scored a green light for its oral antibiotic sulopenem. | Iterum's Orlynvah was approved by the FDA Friday to treat certain uncomplicated urinary tract infections (uUTIs) in adult women who have limited or no alternative antibacterial treatment options.
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