Xepi Approved for Bacterial Skin Infection
December 11, 2017 – The U.S. FDA has approved Xepi™ (ozenoxacin 1%) cream, manufactured by Medimetriks Pharmaceuticals, Inc., to treat impetigo caused by one of two bacterial strains—Staphylococcus aureus or Streptococcus pyogenes—in patients at least two months of age.
Impetigo is a common, highly contagious type of skin infection. In clinical trials, 90.8% of patients who used Xepi had “bacterial success,” which the study defined as the eradication or presumed eradication of the bacteria causing the infection. For patients who received a placebo, 69.8% were found to have bacterial success.
Recommended dosing is a thin layer of Xepi applied to the skin twice a day for five days. The affected area should not be larger than 100cm2 in patients twelve years and up who are prescribed Xepi. For patients between two months and twelve years of age, the affected area should be no more than 2% of total body surface area, not to exceed 100cm2.
Plans for pricing and launch have not yet been announced. However, Xepi is expected to be available in 10gm, 30gm, and 45gm tubes once on the market.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.