1. Pink Sheet
  2. >>Regulatory Trackers
  3. >>US FDA Performance Tracker

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.

Key Takeaways

  • Though no formal vote was taken, the FDA’s Antimicrobial Drugs Advisory Committee did not appear to support Iterum's uUTI antibiotic approval with the proposed labeling.

Iterum is seeking an indication in adult women for the treatment of uncomplicated urinary tract infection (uUTI) caused by designated...

Welcome to Pink Sheet

Create an account to read this article

Already a subscriber?

More from US FDA Performance Tracker

Slowdown: US FDA’s 2025 Novel Approvals Are On Below-Average Pace

 
• By Bridget Silverman

US FDA's 25 novel approvals in 2025 fell short of the agency's five-year average count, driven by a drop in drugs center approvals; 45 user fee goals remain in second half of year.

US FDA’s CRL Release More Incremental Than ‘Radical’ Transparency

 
• By Bridget Silverman

The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 
• By Bridget Silverman

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.

More from Regulatory Trackers

EU CHMP Opinions And MAA Updates

 
• By Neena Brizmohun

This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.

Global Pharma Guidance Tracker - May 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

Upcoming FDA user fee goal dates include novel products from a busy lung cancer pipeline, a single-dose passive immunization against RSV for infants, what could be the first oral HAE acute treatment, and a first-in-class HAE preventive antibody.