Ortho Dermatologics NDA Accepted for Acne Lotion

FDA has accepted for review an Ortho Dermatologics NDA for tazarotene 0.045%) lotion for treating moderate to severe acne. The agency has set a 12/22 user fee review action target date. The submission includes data from two Phase 3 trials in 1,614 patients. The primary efficacy endpoints included the absolute change in the mean noninflammatory and inflammatory lesion counts, the percentage of subjects who had a least a two-grade improvement from baseline to week 12 in the Evaluator Global Severity Score and who had clear or almost clear skin, according to the company. In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance, and the drug was shown to be well-tolerated in the clinical study population, Ortho says. The most common adverse events were application site pain, application site dryness and application site exfoliation.