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FDA approves Utebzi, first oral carbapenem antibiotic for complicated urinary tract infections in adults

Company Fundamentals
17 Jun 2026
GlobeNewsWire
View Source
Bullish
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The FDA has approved Utebzi (tebipenem pivoxil), the first oral carbapenem antibiotic for treating complicated urinary tract infections (cUTIs) in adults with limited oral treatment options. This approval is based on the PIVOT-PO phase III trial showing Utebzi's effectiveness comparable to intravenous treatment. Utebzi offers a convenient oral alternative to IV carbapenems, potentially reducing hospital stays and healthcare costs. It is expected to be available in the US by the end of 2026, providing a new option against resistant infections affecting over 3 million Americans annually.

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