FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Xepi (ozenoxacin topical)

Indication:

Treatment of impetigo caused by Staphylococcus aureus or Streptococcus pyogenes in adults and children aged 2 months or older.

Mechanism:

Topical quinolone antimicrobial. Inhibits bacterial DNA replication enzymes, DNA gyrase A, and topoisomerase IV.

Dosage:

Apply a thin layer topically to affected area q12hr for 5 days; not to exceed 100 cm² area in adults and adolescents or to exceed 2% of body surface area for children aged 2 months to 12 years.

Approval:

Approval was based on two phase 3 multicenter, randomized, double-blind, placebo-controlled studies (n=723). Both phase 3 pivotal studies demonstrated ozenoxacin cream 1% applied topical twice daily for 5 days was superior to placebo on both the clinical and the bacteriological endpoints.

Reference:

Gropper S, et al. Ozenoxacin 1% cream applied topically BID for 5 days: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. Future Microbiol. 2014;9(9):1013-23.

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Cite this: Mary L Windle. FDA New Drug and Biologic Approvals -- 2017 Year-in-Review - Medscape - Jan 11, 2018.