Valeant Says FDA Approves Luzu Cream, 1%

(RTTNews) - Valeant Pharmaceuticals International, Inc. (VRX, VRX.TO) said Friday that the United States Food and Drug Administration has approved the New Drug Application for Luzu Cream, 1%.

Luzu Cream, 1% is indicated for the topical treatment of athlete's foot, jock itch and ringworm, caused by the organisms Trichophyton rubrum and Epidermophyton floccosum, in patients 18 years of age and older.

Luzu, or luliconazole, Cream, 1% is the first topical azole antifungal agent approved to treat jock itch and ringworm with a one-week, once-daily treatment regimen. All other approved treatments require two weeks of treatment. athlete's foot is approved with a two-week, once-daily treatment.

Luzu has been extensively studied in the US, with three positive pivotal studies that were the basis for approval. Luliconazole has been approved in Japan since 2005.