Posted by Michael Wonder on 11 Aug 2025
Gepotidacin accepted for priority review by the US FDA for the oral treatment of uncomplicated urogenital gonorrhoea
11 August 2025 - 11 December assigned as PDUFA goal date for FDA decision
GSK today announced that the US FDA has accepted for priority review a supplemental new drug application for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older (weighing ≥45 kg).
