Retinoid Foam Wins FDA Approval


The FDA has approved Fabior (tazarotene, Stiefel/GSK) Foam, 0.1%, for the treatment of acne vulgaris in patients 12 years and older. The approval was based on two multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3 studies, in which a total of 1,485 patients with moderate-to-severe acne vulgaris were randomized 1:1 to Fabior Foam or vehicle applied once daily for 12 weeks. Investigators evaluated acne severity using lesion counts and the six-point Investigator's Global Assessment (IGA) scale. Patients using Fabior foam experienced a 56 percent reduction in total lesion counts in both studies, as well as a total IGA reduction of 29 percent and 28 percent, respectively. Fabior Foam is contraindicated in pregnancy and may cause fetal harm when administered in pregnant women. Application site irritation, application site dryness, application site erythema, and application site exfoliation were the most common adverse reactions (reported at an incidence greater than or equal to six percent).

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