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GSK's Marketing Application for Urinary Tract Infection Drug Accepted by FDA
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GSK's Marketing Application for Urinary Tract Infection Drug Accepted by FDA
Oct 16, 2024 4:53 AM

07:16 AM EDT, 10/16/2024 (MT Newswires) -- GSK (GSK) said Wednesday that the US Food and Drug Administration has accepted a new drug application for its experimental drug, gepotidacin, to treat uncomplicated urinary tract infections in female adults and adolescents.

The company said the FDA granted priority review for the application and is expected to decide by March 26, 2025.

The company said the phase 3 trials of gepotidacin showed that the drug was non-inferior to nitrofurantoin, the current standard of care, and achieved statistically significant superiority in the EAGLE-3 trial.

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