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FDA Approves Xepi Topical Antibiotic for Impetigo

Medimetriks Pharmaceuticals, Inc. news release; 2017 Dec 14

Medimetriks Pharmaceuticals, Inc. has announced that the US Food and Drug Administration (FDA) approved Xepi (ozenoxacin) cream, 1%, a new chemical entity for the treatment of impetigo in patients aged ≥2 months when applied topically twice daily for 5 days. In the US, impetigo is estimated to account for approximately 10% of skin problems observed in pediatric clinics and is considered the most common bacterial skin infection.

Indications: Xepi is indicated for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes in adult and pediatric patients aged ≥2 months. The safety and effectiveness of Xepi in pediatric patients aged <2 months have not been established.

Dosage/administration: Apply a thin layer of Xepi topically to the affected area twice daily for 5 days. The affected area may be up to 100 cm2 in adult and pediatric patients aged ≥12 years or 2% of the total body surface area and not exceeding 100 cm2 in pediatric patients aged <12 years. Xepi is for topical use only and not for oral, ophthalmic, intranasal, or intravaginal use.

Adverse reactions: Adverse reactions (rosacea and seborrheic dermatitis) were reported in 1 adult patient treated with Xepi.


Medimetriks Pharmaceuticals, Inc. receives FDA approval for Xepi (ozenoxacin) cream, 1%, a novel topical antibiotic for impetigo. [news release]. Fairfield, NJ: Medimetriks Pharmaceuticals, Inc. December 14, 2017. Accessed December 20, 2017.

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Behavioral Counseling to Prevent Skin Cancer, JAMA; 2018 Mar; US Preventative Services Task Force

Therapy-Induced Alopecia Seen in Breast Cancer, JAMA Dermatology; ePub 2018 Apr 11; Freites-Martinez, et al

Melanoma Education Beneficial to African Americans, Dermatolog Surg; 2018 Apr; Tsai, Frank, et al

Intentional Tanning Behaviors of Young Adults, BMC Open; ePub 2018 Apr 3; Daniel, et al

Farm Living Inversely Linked with Skin Allergy, Ann Allergy Asthma Immunol; ePub 2018 Apr 6, Patel, et al

Must Reads in FDA Actions

FDA Approves Ilumya for Plaque Psoriasis, Sun Pharmaceutical Industries Ltd. news release; 2018 Mar

FDA Approves Label Update for Cosentyx, Novartis news release; 2018 Feb 8

FDA Approves Xepi Topical Antibiotic for Impetigo, Medimetriks Pharmaceuticals, Inc. news release; 2017 Dec 14

FDA Approves New Pfizer Biosimilar Ixifi, Pfizer news release; 2017 Dec 13

FDA Clears CoolSculpting for Double Chin Treatment, Allergan plc news release; 2017 Dec 12