Orlynvah Approved for Uncomplicated UTIs After Initial FDA Rejection and Amid Concerns of Antimicrobial Resistance
XTalks
OCTOBER 29, 2024
Iterum Therapeutics has won approval from the US Food and Drug Administration (FDA) for Orlynvah (oral sulopenem) to treat uncomplicated urinary tract infections (uUTIs) caused by E. Based on this data, the FDA rejected Iterum’s application in 2021 and asked Iterum to do a second study “potentially using a different comparator drug.”
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