The FDA Has Accepted Us Marketing Application For GSK's Gepotidacin, An Oral Antibiotic For Adult And Adolescent Females For Uncomplicated Urinary Tract Infections, 26 March 2025 Assigned As Action Date For FDA Decision
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The FDA has accepted the US marketing application for GSK's gepotidacin, an oral antibiotic for uncomplicated urinary tract infections (uUTIs) in adult and adolescent females. The decision date is set for March 26, 2025. Gepotidacin could be the first new class of oral antibiotic for uUTIs in over 20 years, supported by positive phase III trial results.
October 16, 2024 | 10:37 am
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GSK's gepotidacin, an oral antibiotic for uUTIs, has had its US marketing application accepted by the FDA, with a decision expected by March 26, 2025. This could be the first new class of oral antibiotic for uUTIs in over 20 years.
The acceptance of the FDA application is a significant regulatory milestone for GSK, indicating potential future revenue from gepotidacin if approved. The novelty of the drug being the first in a new class for over 20 years adds to its market potential.
CONFIDENCE 95
IMPORTANCE 85
RELEVANCE 90