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Xepi Approval History

Xepi (ozenoxacin) is a topical non-fluorinated quinolone for the treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

Information for Patients

  • Xepi is usually applied as a thin layer to the affected area twice daily for five days.
  • Always use Xepi as directed by your healthcare practitioner. Wash your hands after applying the cream if the hands are not the area for treatment.
  • Xepi is for external use only. Do not swallow the cream, or use it in the eyes, on the mouth or lips, inside the nose, or inside the female genital area.
  • The treated area may be covered by a sterile bandage or gauze dressing.
  • Use Xepi for the entire time as recommended by your healthcare practitioner, even though your symptoms may have improved.
  • Notify your healthcare practitioner if there is no improvement in symptoms within three days of starting treatment.

Development History and FDA Approval Process for Xepi

DateArticle
Dec 14, 2017Approval Medimetriks Pharmaceuticals, Inc. Receives FDA Approval for Xepi (ozenoxacin) Cream 1%, a Novel Topical Antibiotic for Impetigo
Jun 27, 2016Medimetriks Pharmaceuticals, Inc. Submits NDA to FDA for Ozenoxacin Cream for Impetigo
Aug  2, 2015Cipher Pharmaceuticals Announces Successful Completion of Second Phase III for Ozenoxacin
Jun  5, 2013Ferrer successfully completes a phase III clinical trial in adult and paediatric patients with impetigo for novel antibacterial compound Ozenoxacin
Oct  5, 2012Ferrer Successfully Completes An Absorption, Tolerability and Safety Study in Juveniles As Young As Two Months of Age for Novel Antibacterial Compound Ozenoxacin

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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