Quick answers
- What is Finafloxacin used for?
- The FDA-approved label (Xtoro, Fonseca Biosciences, LLC, March 24, 2026) says: “XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Finafloxacin have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Finafloxacin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Finafloxacin been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Finafloxacin?
- 1 company lists prescription products of Finafloxacin in the FDA NDC Directory, including Fonseca Biosciences, LLC.
What Finafloxacin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
XTORO® is indicated for the treatment of acute otitis externa (AOE) with or without an otowick, caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus in patients age 1 year and older. XTORO® is a quinolone antimicrobial indicated for the treatment of acute otitis externa (AOE) caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus.
— FDA label: Xtoro, Fonseca Biosciences, LLC, effective March 24, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Suspension |
|---|---|
| Route | Auricular (otic) |
| Prescription products | 1 in the FDA NDC Directory |
| Brand names | Xtoro |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Fonseca Biosciences, LLC1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA206307 XTORO | Fonseca Biosciences | December 17, 2014 | 3, latest March 18, 2026 2026: Labeling · 2026: Labeling · 2015: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 1598645, 1598650 |
|---|---|
| SPL set ID of the quoted label | 5c628272-019e-4511-8d5c-dcf56023da25 |
| FDA labels (SPL) | 1 |
| FDA applications | NDA206307 |
| Active ingredients (FDA) | FINAFLOXACIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Xtoro, Fonseca Biosciences, LLC, effective March 24, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →