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Xepi Approval History

FDA Approved: Yes (First approved December 11, 2017)
Brand name: Xepi
Generic name: ozenoxacin
Dosage form: Cream
Company: Medimetriks Pharmaceuticals, Inc.
Treatment for: Impetigo

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

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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