Stiefel, a GlaxoSmithKline plc (GSK,GSK.L) company, said Friday that the US Food and Drug Administration has approved the New Drug Application for Fabior, or tazarotene, Foam, 0.1%.
It is the only retinoid in a topical foam formulation 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, North America Dermatology.
The approval of tazarotene foam was based on two multi-center, randomized, double-blind, vehicle-controlled pivotal Phase 3 studies conducted in the US and Canada.
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