Prescription medicine
Finafloxacin Brand names: Xtoro
Finafloxacin (Xtoro) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the finafloxacin FDA label on DailyMed (effective March 24, 2026, Fonseca Biosciences, LLC); the NDA 206307 record on Drugs@FDA; every finafloxacin label on DailyMed.
Highlights of the record
FDA label of March 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageXTORO® 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.
Forms and strengths
- 3 mg/ml
Suspension.
On the market
- Earliest approval on file
- December 17, 2014 Xtoro, Fonseca Biosciences; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 21, 2033 Xtoro suspension/drops; 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
- FAERS reports
- 1 through July 30, 2026
What is finafloxacin used for?
From the label: indications and usageXTORO® 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 pharmacologic class: Quinolone Antimicrobial.
Source: FDA drug label (XTORO), Fonseca Biosciences, LLC, effective March 24, 2026 (SPL set 5c628272-019e-4511-8d5c-dcf56023da25), via openFDA; the full label on DailyMed
Is there a generic for finafloxacin (Xtoro)?
No generic finafloxacin is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 4 patents for Xtoro suspension/drops, the last expiring on November 21, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for finafloxacin?
The FDA Adverse Event Reporting System holds 1 report that list finafloxacin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 0 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other quinolone antimicrobials
- the pharmacologic class, with prices and generics
- Finafloxacin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other