FDA Approves Fabior Foam

Stiefel Receives US FDA Approval of Fabior Foam, 0.1%

RESEARCH TRIANGLE PARK, N.C., May 11, 2012 /PRNewswire/ -- 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%. 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 factors, including hormonal changes, heredity and genetics, certain medications, and greasy cosmetics.[2]

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

For more information about Fabior Foam please see the Full US Prescribing Information at http://www.stiefel.com/content/dam/stiefel/globals/documents/pdf/US_Fabior.pdf

GlaxoSmithKline plc – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit www.gsk.com

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. To learn more about Stiefel, visit www.stiefel.com.

Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2011.

References

[1] American Academy of Dermatology. Acne: Who gets and causes. Available at http://www.aad.org/skin-conditions/dermatology-a-to-z/acne/who-gets-causes/acne-who-gets-and-causes. Accessed 26 April, 2012.

[2] 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. Available at http://www.niams.nih.gov/Health_Info/Acne/default.asp. Accessed 26 April, 2012.

SOURCE GSK


CONTACT: UK Media: David Mawdsley, +44 (0) 20 8047 5502 (London); Stephen Rea, +44 (0) 20 8047 5502 (London); Sarah Spencer, +44 (0) 20 8047 5502 (London); David Daley, +44 (0) 20 8047 5502 (London); US Media: Robin Gaitens, +1-919-483-2678 (North Carolina); Analyst/Investor: Sally Ferguson, +44 (0) 20 8047 5543 (London); Tom Curry, +1-215-751-5419 (Philadelphia); Gary Davies, + 44 (0) 20 8047 5503 (London); Jeff McLaughlin, +1-215-751-7002 (Philadelphia); Ziba Shamsi, + 44 (0) 20 8047 3289 (London)

Web Site: http://www.gsk.com
 

Posted: May 2012

Fabior (tazarotene) FDA Approval History

View comments

Hide
(web5)