GSK (GSK) plc announced that the US Food and Drug Administration, FDA, has accepted for priority review a supplemental New Drug Application, NDA, for gepotidacin as an oral option for the treatment of uncomplicated urogenital gonorrhoea in patients 12 years of age and older. The US FDA has assigned a Prescription Drug User Fee Act action date of 11 December 2025. In March 2025, gepotidacin was approved by the US FDA under the licensing name Blujepa as oral treatment for female adult and paediatric patients 12 years of age and older with uncomplicated urinary tract infection. This is the second major indication filed in the US for gepotidacin, and review of regulatory submissions for the uUTI indication is also ongoing in the UK and Australia.
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