On Thursday, the U.S. Food and Drug Administration (FDA) approved GSK Plc’s (NYSE:GSK) supplemental New Drug Application for gepotidacin as an oral option for uncomplicated urogenital gonorrhoea.

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Gonorrhoea is a common, sexually transmitted infection caused by Neisseria gonorrhoeae.

GSK said, in 2023, there were over 600,000 cases of gonorrhoea reported in the United States according to the CDC, making it the second most commonly reported sexually transmitted infection in the country.

The approval covers adult and pediatric patients from 12 years of age weighing at least 45 kg who have limited or no alternative options for uncomplicated urogenital gonorrhoea caused by susceptible strains of Neisseria gonorrhoeae.

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