The FDA has approved Stiefel's new drug application (NDA) for Fabior (tazarotene) foam, 0.1%, to treat acne vulgaris in patients 12 years of age and older.
North America Dermatology vice president Jean-Christophe May said, "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."
The approval was based on two multi-center, double-blind, vehicle-controlled pivotal Phase III studies conducted in the US and Canada.
The most common adverse reactions reported were application site erythema, application site irritation, application site dryness and application site exfoliation.
Tazarotene foam may cause fetal harm when administered in pregnant women, the company said.
