Stiefel receives US FDA approval of Fabior™ Foam, 0.1%

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%. 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.

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.

About Acne Vulgaris

Acne is the most common skin problem in the US, affecting about 40 – 50 million Americans at any one time. [i] 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 factors, including hormonal changes, heredity and genetics, certain medications, and greasy cosmetics. [ii]

Important Safety Information

Fabior Foam is contraindicated in pregnancy and may cause fetal harm when administered in pregnant women. Females of childbearing potential should have a negative pregnancy test within two weeks prior to initiating treatment and use an effective method of contraception during treatment.

It should be used with caution in patients with a history of local tolerability reactions or local hypersensitivity. Concomitant topical acne therapy should be used with caution because a cumulativeirritant effect may occur. Because of increased photosensitivity and risk of sunburn, patients should avoid exposure to sunlight, sunlamps, and weather extremes, and should wear sunscreen daily. The propellant in Fabior Foam is flammable so patients should be instructed to avoid fire, flame, and smoking during and immediately following application. The most common adverse reactions reported at an incidence ≥ 6% are application site irritation, application sitedryness, application site erythema, and application site exfoliation.

For more information about Fabior Foam please see the Full US Prescribing Information.

References

[i] American Academy of Dermatology. Acne: Who gets and causes. Accessed 26 April, 2012.

[ii] US Department of Health and Human Services, National Institutes of Health, and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Questions and Answers about Acne. October 2010. Accessed 26 April, 2012.