Iterum Stock Nosedives As FDA Flags Deficiencies In Sulopenem Application
Iterum Therapeutics received an FDA letter about deficiencies in the sulopenem etzadroxil/probenecid application for uncomplicated UTIs, delaying labeling and post-marketing discussions. The FDA did not detail the issues, stating this isn't a final decision. A review completion goal is set for July 25. Iterum plans to address the deficiencies with the FDA.
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Iterum Stock Nosedives As FDA Flags Deficiencies In Sulopenem Application
Iterum Therapeutics received an FDA letter about deficiencies in the sulopenem etzadroxil/probenecid application for uncomplicated UTIs, delaying labeling and post-marketing discussions. The FDA did not detail the issues, stating this isn't a final decision. A review completion goal is set for July 25. Iterum plans to address the deficiencies with the FDA.