FDA News

FDA expands use of Luzu for fungal infections in children

The FDA recently approved expanded use of Luzu cream for patients aged 12 years and older with interdigital tinea pedis and tinea cruris and for patients aged 2 years and older with tinea corporis, caused by the organisms Trichophyton rubrum and Epipdermophyton floccosum, according to Ortho Dermatologics.

 “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,” Bill Humphries, executive vice president of dermatology for Ortho Dermatologics, said in a press release. “We are pleased that the FDA has recognized the benefit of treatment with Luzu for pediatric patients.”

Luzu (luliconazole cream 1%, Valeant Pharmaceuticals North America), a topical azole antifungal agent, was originally approved for treating tinea cruris and tinea corporis in adults with a once-a-week, one-daily treatment plan, compared with other approved treatments that require at least a 2-week regimen, according to the release.

Two postmarketing studies of luliconazole cream, 1% were used by the FDA for the approval of Ortho Dematologics’ supplemental new drug application, according to the release. The first study measured pharmacokinetics under minimal use conditions in patients aged 12 to younger than 18 years with interdigital tinea pedis or tinea cruris. The second study measured safety, efficacy and pharmacokinetics in patients aged 2 years to younger than 18 years with tinea corporis when luliconzole cream, 1% was applied twice daily for seven days.

Ortho Dermatologics is a division of Valeant Pharmaceuticals North America, LLC.

The FDA recently approved expanded use of Luzu cream for patients aged 12 years and older with interdigital tinea pedis and tinea cruris and for patients aged 2 years and older with tinea corporis, caused by the organisms Trichophyton rubrum and Epipdermophyton floccosum, according to Ortho Dermatologics.

 “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,” Bill Humphries, executive vice president of dermatology for Ortho Dermatologics, said in a press release. “We are pleased that the FDA has recognized the benefit of treatment with Luzu for pediatric patients.”

Luzu (luliconazole cream 1%, Valeant Pharmaceuticals North America), a topical azole antifungal agent, was originally approved for treating tinea cruris and tinea corporis in adults with a once-a-week, one-daily treatment plan, compared with other approved treatments that require at least a 2-week regimen, according to the release.

Two postmarketing studies of luliconazole cream, 1% were used by the FDA for the approval of Ortho Dematologics’ supplemental new drug application, according to the release. The first study measured pharmacokinetics under minimal use conditions in patients aged 12 to younger than 18 years with interdigital tinea pedis or tinea cruris. The second study measured safety, efficacy and pharmacokinetics in patients aged 2 years to younger than 18 years with tinea corporis when luliconzole cream, 1% was applied twice daily for seven days.

Ortho Dermatologics is a division of Valeant Pharmaceuticals North America, LLC.