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Iterum Scores First Approval For Oral Penem Antibiotic

 
• By Alaric DeArment

The US FDA approved Orlynvah for uncomplicated urinary tract infections among adult women, despite some concerns about the potential for off-label use and resistance.

Antibiotic resistant bacteria closeup biofilm

Iterum Therapeutics plc’s Orlynvah (sulopenem etzadroxil and probenecid) has become the first new antibiotic for uncomplicated urinary tract infections (uUTI) in women in two decades and the first oral member of the penem class to win approval from the US Food and Drug Administration, despite some concerns raised by an FDA advisory committee.

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Pipeline Watch: Ten Approvals And Eleven Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.