gepotidacin (Blujepa): FDA status

Approved Approved Mar 25, 2025. Indication: uncomplicated urinary tract infection in female adults and adolescents. Company: GSK.

Regulatory history

• Mar 25, 2025: Approved. FDA approved gepotidacin for treatment of uncomplicated urinary tract infections in female adults and adolescents 12 years and older weighing 40 kg or more urologytimes.com
• Oct 16, 2024: Priority review. Gepotidacin accepted for priority review by FDA for treatment of uncomplicated UTIs in female adults and adolescents ajmc.com

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