FDA approves Luzu (Valeant Pharma) for Fungal Infections

The FDA has approved a New Drug Application for Luzu (luliconazole) Cream, 1%, from Valeant Pharmaceuticals International, for the topical treatment of Fungal Infections athlete's foot (interdigital tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis), caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older. Approval is based on three pivotal studies, conducted in 679 subjects with either tinea pedis or tinea cruris.

In Study 1, 26% of subjects with tinia pedis treated with Luzu were completely cleared, compared to only 2% of subjects treated with vehicle. In Study 2, 14% of subjects with tinia pedis treated with Luzu were completely cleared, compared to only 3% of subjects treated with vehicle. For the pivotal study in tinea cruris, 21% of subjects treated with Luzu were completely cleared after 1 week, compared to only 4% of subjects treated with vehicle. The most common adverse events were mild application site reactions, reported in less than one percent of subjects.