Luzu Cream Approved for Skin Fungal Infections
Valeant announced that the New Drug Application for Luzu (luliconazole) Cream, 1% has been approved by the FDA.
Luzu Cream is an azole antifungal 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 old.
The FDA approval is based on the results of three positive studies that evaluated 679 patients with either athlete's foot or jock itch. Two studies evaluating athlete's foot had a primary endpoint of complete clearance at 4 weeks post-treatment.
In Study 1, 26% of patients treated with Luzu were completely cleared vs. only 2% of patients treated with vehicle. In Study 2, 14% of patients treated with Luzu were completely cleared vs. only 3% of patients treated with vehicle.
In the study evaluating jock itch, complete clearance was assessed at 3 weeks post-treatment. After one week of treatment, 21% of patients treated with Luzu were completely cleared vs. 4% of patients treated with vehicle.
For more information call (800) 556-1937 or visit Valeant.com.