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US FDA Advisors Want Iterum’s Antibiotic Indication Narrowed

 
• By Sarah Karlin-Smith

The agency’s Antimicrobial Drugs Advisory Committee suggested a more limited indication for Interum’s antibiotic for uncomplicated urinary tract infections than the sponsor proposed, though it wasn’t necessarily clear committee members favored approval.

Sulopenem advisory committee meeting
The FDA held the first fully in-person advisory committee since the emergence of COVID-19 on 9 September at its Maryland headquarters. • Source: Sarah Karlin-Smith

Iterum Therapeutics plc’s oral antibiotic sulopenem etzadroxil/probenecid for uncomplicated urinary tract infections could be headed for US Food and Drug Administration approval, albeit with a much narrower label than proposed before the 9 September Antimicrobial Drugs Advisory Committee meeting.

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