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Regulatory update – Stiefel, a GSK company, files NDA for tazarotene foam

Stiefel, a GSK company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for tazarotene foam for the topical treatment of facial acne vulgaris in patients 12 years of age or older.

Issued: Wednesday 03 August 2011, London UK

Stiefel, a GSK company, announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), for tazarotene foam for the topical treatment of facial acne vulgaris in patients 12 years of age or older.

Tazarotene foam will be subject to evaluation and approval by the regulatory authorities before it can be made available to physicians for prescribing to their appropriate patients.

Notes to Editors

As the result of a Supply and Commercialisation Agreement Allergan, Inc. has, for a 3-month period after Stiefel’s submission of documents requesting regulatory approval in a territory, the right to negotiate with Stiefel to enter into a co-promotion agreement, whereby Allergan would have the exclusive right to promote and detail tazarotene foam to a defined target audience, for a specified co-promotion period, on terms that are mutually acceptable to Allergan and Stiefel in each party’s sole discretion.

About Stiefel, a GSK company

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.

GlaxoSmithKline – 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.

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GlaxoSmithKline cautionary statement regarding forward-looking statementsUnder 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 2010.