Navigation Links
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 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
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Perrigo and Partner Cobrek Confirms Filing for Generic Version of Evoclin(R) and Announcement of Lawsuit by Stiefel
2. Prasco and Stiefel Sign Distribution and Supply Agreement for Clobetasol Propionate Foam
3. RoundTable Healthcare Partners Names Charles W. Stiefel as Senior Advisor
4. Stiefel Launches Most-Prescribed BPO Wash Formulations Over-the-Counter
5. Reclast(R) Receives US FDA Approval as First and Only Once-Yearly Treatment for Women With Postmenopausal Osteoporosis
6. Indevus Receives Approvable Letter From FDA for VALSTAR(R) for Bladder Cancer Therapy
7. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
8. Abbott Receives Supplemental FDA Approval for its Best-in-Class in Sensitivity RealTime HIV-1 Viral Load Test
9. GlaxoSmithKline Receives New HHS Order for H5N1 Bulk Antigen. First North American Clinical Trials with GSKs Candidate Pre-pandemic Flu Vaccine to Start.
10. CryoCor Receives FDA Approval for Right Atrial Flutter
11. Ranbaxy Receives Approval to Manufacture and Market Hydrocodone Bitartrate and Acetaminophen Tablets USP
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/24/2016)... 2016 Research and Markets ... Electronics 2015-2025: Applications, Technologies, Forecasts" report to ... In-Mold Electronics, Smart Skin, Structural Health Monitoring, Composite ... Structural electronics involves electronic and/or electrical components and ... dumb structures such as vehicle bodies or conformally ...
(Date:6/24/2016)... India , June 24, 2016 ... Needles Market by Type (Standard Pen Needles, Safety Pen ... Therapy (Insulin, GLP-1, Growth Hormone), Mode of Purchase (Retail, ... by MarketsandMarkets, This report studies the market for the ... expected to reach USD 2.81 Billion by 2021 from ...
(Date:6/23/2016)... , June 23, 2016 Research and ... Global Market - Forecast to 2022" report to their ... treatment method for the patients with kidney failure, it replaces ... fluid from the patient,s blood and thus the treatment helps ... and chloride in balance. Increasing number of ...
Breaking Medicine Technology:
(Date:6/26/2016)... ... 2016 , ... On June 10-11, 2016, A Forever Recovery, a holistic treatment ... Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is located. This ... of the world’s leading providers of cereal and other breakfast foods. Its residents often ...
(Date:6/25/2016)... ... June 25, 2016 , ... ... and applications at AcademyHealth’s Annual Research Meeting June 26-28, 2016, at the Hynes ... important health care topics including advance care planning, healthcare costs and patient and ...
(Date:6/25/2016)... ... 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his ... David Geffen School of Medicine at UCLA. He trained in Internal Medicine at Scripps ... in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to ...
(Date:6/24/2016)... ... ... Those who have experienced traumatic events may suffer from a complex set ... drug or alcohol abuse, as a coping mechanism. To avoid this pain and suffering, ... traumatic event. , Trauma sufferers tend to feel a range of emotions, from depression, ...
(Date:6/24/2016)... Francisco, CA (PRWEB) , ... June 24, 2016 ... ... CitiDent, is now offering micro-osteoperforation for accelerated orthodontic treatment. Dr. Cheng has extensive ... self-ligating Damon brackets , AcceleDent, and accelerated osteogenic orthodontics. , Micro-osteoperforation ...
Breaking Medicine News(10 mins):