FDA approves new oral treatment for uncomplicated UTI in adult women
The US Food and Drug Administration has approved a new oral antibiotic for treatment of uncomplicated urinary tract infections (uUTIs) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options.
Orlynvah is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI).
Orlynvah is taken as one oral tablet twice daily for 5 days.
Disease or Condition
An uncomplicated UTI is a bacterial infection of the bladder in women with no structural abnormalities of their urinary tract. Approximately one-half of all women will experience at least one uUTI in their lifetime.
Effectiveness
The effectiveness of Orlynvah was evaluated in two phase 3 controlled, randomized, double blind clinical trials (Trial 1 and Trial 2) which enrolled adult women with uUTI. Orlynvah was administered as one tablet twice daily for 5 days.
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