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Stiefel receives US FDA approval of Fabior™ Foam, 0.1%
Date:5/11/2012

RESEARCH TRIANGLE PARK, N.C., May 11, 2012 /PRNewswire/ -- Stiefel, a GSK (NYSE: GSK) company, today announced that the US Food and Drug Administration has approved the New Drug Application for Fabior (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. More information about the clinical trial results can be found in the Full US Prescribing Information at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Fabior.pdf.

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 site dryness, application site erythema, and application site exfoliation.

About Acne Vulgaris

Acne is the most common skin problem in the US, affecting about 40 – 50 million Americans at any one time.[1] Acne can affect anyone at any age but it is most common in adolescents and young adults. Hormones and other substances can act on the skin's oil (sebaceous) glands and hair follicles, leading to clogged pores and outbreaks commonly known as pimples. While the exact cause of acne is unknown, researchers believe it results from several
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