WHA
 

Xtoro (finafloxacin otic suspension)

Indications for Prior Authorization

Xtoro (finafloxacin otic suspension)
  • For diagnosis of Acute Otitis Externa (AOE)
    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.

Criteria

Xtoro

Step Therapy

Length of Approval: 7 Day(s) [A, 1]

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 7-day supply), contraindication, or intolerance to three of the following generics: [B-C]
    • ofloxacin otic solution
    • ciprofloxacin otic solution
    • ciprofloxacin/hydrocortisone otic suspension
    • ciprofloxacin/dexamethasone otic suspension
    • neomycin-polymyxin B—hydrocortisone otic solution or suspension
    • acetic acid 2% otic solution
    • acetic acid 2% - hydrocortisone 1% otic solution

  • Guideline ID
    GL-652280

  • Formulary
    Premium

  • Effective date
    Sep 1, 2026

  • P&T approval date
    Aug 20, 2026

P & T Revisions

2026-07-21

  1. Xtoro Prescribing Information. Fonseca Biosciences, LLC. Long Beach Township, New Jersey. March 2026.
  2. Block, S.Otitis externa: Providing relief while avoiding complications. Available at: https://www.mdedge.com/jfponline/article/60373/infectious-diseases/otitis-externa-providing-relief-while-avoiding/page/0/. Accessed July 14, 2026.
  3. Ellis, J., De La Lis, A., Rosen, E., et al. Approach to otitis externa. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC11477254/. Accesed July 14, 2026.
  4. Rosenfeld, R., Schwartz, S., Cannon, C., et al. Clinical Practice Guideline: Acute Otitis Externa. Available at: https://aao-hnsfjournals.onlinelibrary.wiley.com/doi/10.1177/0194599813517083. Accessed July 14, 2026.
  5. Acute Otitis Externa: Rapid Evidence Review. American Family Physician. Available at: https://www.aafp.org/afp/2023/0200/acute-otitis-externa. Accessed July 14, 2026.
  6. Waitzman, A. Otitis Externa Treatment & Management. Available at: https://emedicine.medscape.com/article/994550-treatment. Accessed July 14, 2026.
  1. Dosage and Administration: 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. [1]
  2. The mainstay of treatment is topical ear drops containing antibiotics with or without corticosteroids to reduce inflammation [4-6]
  3. There are not any meaningful differences in clinical outcomes based on class of drug (antibiotic vs antiseptic), use of a quinolone versus a nonquinolone preparation, or for monotherapy versus combination drugs with or without a concurrent steroid. [4]
  • 2026-07-21: New ST guideline