Stiefel receives US FDA approval of Fabior Foam, 0.1%

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Stiefel, a GSK company, today announced that the US Food and Drug Administration has approved the New Drug Application for Fabior (tazarotene) Foam, 0.1%. Itis 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. 

According to GlaxoSmithKline, 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. More information about the clinical trial results can be found in the Full US Prescribing Information.

Tazarotene foam 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 sitedryness, application site erythema, and application site exfoliation.

 

 

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