The United States Food and Drug Administration has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1% from Stiefel. It is currently the only retinoid available in a topical foam formulation indicated for the treatment of acne vulgaris in patients 12 years of age and older. “Stiefel is dedicated to meeting the needs of patients and dermatologists, and we believe Fabior Foam will be an important treatment option for people with moderate-to-severe acne,” said Jean-Christophe May, vice president of North America dermatology, Stiefel.
Approval of tazarotene foam was based on two multi-center, randomized, double-blind, vehicle-controlled pivotal Phase III studies conducted in the U.S. and Canada. It is contraindicated in pregnancy and may cause fetal harm when administered in pregnant women. The most common adverse reactions reported at an incidence > 6% were application site irritation, application site dryness, application site erythema, and application site exfoliation.