Prescription medicine

Zoliflodacin Brand names: Nuzolvence

Zoliflodacin (Nuzolvence) is a prescription medicine with an FDA approval on record since 2025. No generic is listed in FDA's NDC Directory.

No generic listed

Check it at the source: the zoliflodacin FDA label on DailyMed (effective December 22, 2025, La Jolla Pharmaceutical Company); the NDA 219491 record on Drugs@FDA; every zoliflodacin label on DailyMed.

Highlights of the record

FDA label of December 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage
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.

Forms and strengths

For suspension.

On the market

Earliest approval on file: December 12, 2025 Nuzolvence, Entasis Therap; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Last listed patent: January 21, 2034 Nuzolvence for oral suspension; not a generic launch date

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is zoliflodacin used for?

From the label: indications and usage
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. […]

Source: FDA drug label (NUZOLVENCE), NDA219491 (Entasis Therap), as published by La Jolla Pharmaceutical Company, effective December 22, 2025 (SPL set 4beda35a-21b0-4b34-84ea-be6ea8cae50f), via openFDA; the full label on DailyMed

What does the patient leaflet for zoliflodacin say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about NUZOLVENCE?
NUZOLVENCE may cause serious side effects, including: fetal harm. It is not known if NUZOLVENCE can harm your unborn baby. Females: Your healthcare provider should have you take a pregnancy test before you receive NUZOLVENCE. If you take NUZOLVENCE while you are pregnant, your baby may be at risk for serious birth defects. Males: Males with female partners who can become pregnant should use effective contraception for at least 90 days (3 months) after treatment with NUZOLVENCE. harm to testicles. NUZOLVENCE may be harmful to testicles and lower sperm count in males and cause fertility problems. NUZOLVENCE may harm your sperm. allergic reactions. Allergic reactions, including rash and itching, have been reported in people receiving NUZOLVENCE. diarrhea caused by Clostridioides difficile infection. Antibiotics can sometimes cause a type of severe diarrhea called Clostridioides difficile infection (CDI). CDI is a severe infection of the intestines (bowels) that can be serious or life-threatening. CDI can happen up to 2 months after finishing treatment with NUZOLVENCE. Call your healthcare provider right away if you develop frequent, watery, or bloody stools, or stomach cramps that are severe, do not go away, or come back, after taking NUZOLVENCE.

From the patient leaflet: How should I store NUZOLVENCE?
Store NUZOLVENCE at room temperature between 68 °F to 77 °F (20 °C to 25 °C) in the original packaging. Do not freeze. Keep NUZOLVENCE and all medicines out of the reach of children.

Is there a generic for zoliflodacin (Nuzolvence)?

No generic zoliflodacin is approved (Drugs@FDA, October 8, 2026).

The Orange Book lists 6 patents for Nuzolvence for oral suspension: the compound patent runs to January 21, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.

2025 earliest approval on file
2034 last listed patent

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What next?

Check an interaction: what two or more labels say about each other