FDA Approves Label Extension for Topical Treatment

02/22/2018
ointment

The FDA has approved the Supplemental New Drug Application for the use of luliconazole cream, 1% (Luzu), to include pediatric patients from aged 2 years and older with tinea corporis caused by Trichophyton rubrum and Epidermophyton floccosum and patients aged 12 years and older with interdigital tinea pedis or tinea cruris.

Luliconazole cream, 1%, is a topical treatment that was initially approved by the FDA in 2013 for adults.
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Approval for this expansion was based on 2 studies that evaluated the safety, efficacy and pharmacokinetics of luliconazole among children with interdigital tinea pedis and tinea cruris aged 12 to 18 years and among children with tinea corporis aged 2 to 18 years.

Common adverse effects associated with luliconazole cream, 1%, include skin reactions or irritation at treatment site.

—Melissa Weiss