Molecule
Finafloxacin is a quinolone antimicrobial 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. MedsAcross supplies Finafloxacin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Finafloxacin is a fluoroquinolone antimicrobial.
Source: US FDA prescribing information
Instill four drops into the affected ear(s) twice daily for seven days. For patients requiring use of an otowick, the initial dose can be doubled (to 8 drops), followed by 4 drops instilled into the affected ear twice daily for seven days. Important administration instructions include: Warm the suspension by holding the bottle in the hand for one or two minutes prior to dosing in order to avoid dizziness which may result from the instillation of a cold suspension. Shake bottle well before use. Lie with the affected ear upward, instill the drops, and maintain the position for 60 seconds to facilitate penetration of the drops into the ear canal. Repeat if necessary for the opposite ear. Instill four drops in the affected ear(s) twice daily for seven days.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Prolonged use of this product may lead to overgrowth of nonsusceptible organisms. Discontinue use if this occurs. Allergic reactions may occur in patients with a history of hypersensitivity to finafloxacin, to other quinolones, or to any of the components in this medication.
Source: US FDA prescribing information
The most common adverse reactions occurring in 1% of patients with XTORO were ear pruritus and nausea.
Source: US FDA prescribing information
Store at 2°C to 25°C (36°F to 77°F). Do not freeze.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Finafloxacin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Xtoro 3 mg/mL otic suspensionOtic | Fonseca Biosciences | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 17 December 2014 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Finafloxacin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 1 presentations of Finafloxacin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Finafloxacin, including Xtoro.
Yes. The US FDA first approved Finafloxacin on 17 December 2014, according to Drugs@FDA.
No listed presentation of Finafloxacin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.