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. https://www.prnewswire.com/news-releases/medimetriks-pharmaceuticals-inc-receives-fda-approval-for-xepi-ozenoxacin-cream-1-a-novel-topical-antibiotic-for-impetigo-300571024.html. Accessed December 20, 2017.
This Week's Must Reads
Nevus Development Trajectory from Age 3 to 16 Years, JAMA Dermatology; ePub 2018 Sep 12; Asdigian, et al
Pruritis Strongly Associated with Certain Cancers , J Am Acad Dermatol; ePub 2018 Sep 11; Larson, et al
Trends in Medicare Billing Among Mohs Surgeons, Dermatolog Surg; ePub 2018 Sep 7; Tsai, et al
Mohs Surgery Effective for Invasive Melanomas, Dermatolog Surg; ePub 2018 Sep 7; Degesys, et al
Young Adults with Psoriasis Have Impaired QOL, J Dermatolog Treat; ePub 2018 Sep 7; Bronckers, et al
Must Reads in FDA Actions
FDA Approves Qbrexza for Excessive Armpit Sweating, Dermira Inc. news release; 2018 Jun 29
FDA Approves Drug Combination for Melanoma, Array BioPharma news release; 2018 Jun 27
FDA Approves Rituxan for Pemphigus Vulgaris, Genentech Web site; 2018 Jun 7
FDA Extends Label for Cimzia for Plaque Psoriasis, UCB news release; 2018 May 29
FDA Updates Label for Taltz for Genital Psoriasis, PharmaLive news release; 2018 May 22