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FDA Medication Tracker

← All approvals · Infections & vaccines · 2025

Nuzolvence (zoliflodacin)

The FDA approved Nuzolvence (zoliflodacin) on December 12, 2025 to treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae.
Brand name
Nuzolvence
Generic name
zoliflodacin
FDA approval date
December 12, 2025
Approved use (FDA wording)
To treat uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae
Company
Entasis Therap
Application
NDA219491
Dosage form / route
FOR SUSPENSION · ORAL
Boxed warning on label
Not listed
Category on this site
Infections & vaccines

Indications and usage, from the FDA label

NUZOLVENCE is a spiropyrimidinetrione bacterial type II topoisomerase inhibitor indicated for the treatment of uncomplicated urogenital gonorrhea due to Neisseria gonorrhoeae in adults and pediatric patients 12 years of age and older, weighing at least 35 kg. ( 1.1 ) Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of NUZOLVENCE and other antibacterial drugs, NUZOLVENCE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. ( 1.2 ) 1.1 Uncomplicated Urogenital Gonorrhea NUZOLVENCE is indicated for the treatment of uncomplicated urogenital gonor…

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.