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FDA Medication Tracker

← All approvals · Infections & vaccines · 2025

Blujepa (gepotidacin)

The FDA approved Blujepa (gepotidacin) on March 25, 2025 to treat uncomplicated urinary tract infections.
Brand name
Blujepa
Generic name
gepotidacin
FDA approval date
March 25, 2025
Approved use (FDA wording)
To treat uncomplicated urinary tract infections
Company
Glaxosmithkline
Application
NDA218230
Dosage form / route
TABLET · ORAL
Boxed warning on label
Not listed
Category on this site
Infections & vaccines

Indications and usage, from the FDA label

BLUJEPA is a triazaacenaphthylene bacterial type II topoisomerase inhibitor indicated for the treatment of the following infections caused by susceptible microorganisms: • Uncomplicated urinary tract infections (uUTI) in female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg). ( 1.1 ) • Uncomplicated urogenital gonorrhea in adult and pediatric patients 12 years of age and older weighing at least 45 kilograms who have limited or no alternative treatment options. Approval of this indication is based on limited clinical safety data for this indication. ( 1.2 , 6.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug…

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.