The US Food and Drug Administration has approved Stiefel's, a GSK company, New Drug Application for Fabior (tazarotene) Foam, 0.1 per cent. 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-centre, randomized, double-blind, vehicle-controlled pivotal phase III studies conducted in the US and Canada.

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 per cent were application site irritation, application sitedryness, application site erythema, and application site exfoliation.

Acne is the most common skin problem in the US, affecting about 40 – 50 million Americans at any one time. 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.

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 per cent are application site irritation, application sitedryness, application site erythema, and application site exfoliation.

Stiefel, a GSK company – is committed to advancing Dermatology and skin science around the world in order to help people better achieve healthier skin. Stiefel’s dedication to innovation, along with its focus on pharmaceutical, over-the-counter and aesthetic Dermatology products, has established Stiefel as a world leader in the skin health industry.