Topical Antifungal Approved for Use in Pediatric Patients
The cream is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis.
The Food and Drug Administration (FDA) has approved the use of Luzu Cream, 1% (luliconazole; Ortho Dermatologics) for the treatment of pediatric patients ≥12 years of age. Previously, the treatment had only been approved for those ≥18 years old.
Luzu, an azole antifungal, is indicated for the topical treatment of interdigital tinea pedis, tinea cruris, and tinea corporis caused by the organisms Trichophyton rubrum and Epidermophyton floccosum.
The FDA approval to expand the indication was based on 2 postmarketing requirement studies conducted in pediatric patients.
“Though anyone at any age can get infected with athlete's foot, jock itch and ringworm, because they are very contagious, treatment options are limited for children,” said Bill Humphries, executive vice president of Dermatology, Ortho Dermatologics. “We are pleased that the FDA recognized the benefits of treatment with Luzu for pediatric patients."
Luzu Cream, 1% is supplied in 60g tubes; each gram contains 10 mg of luliconazole.
Ortho Dermatologics receives US FDA approval for expanded use of Luzu (luliconazole) cream, 1% in pediatric patients with athelete's food, jock itch and ringworm [press release]. Raleigh, NC: Ortho Dermatologics; February 22, 2018. Accessed March 5, 2018.