Wellbutrin XL - FDA Letter

GlaxoSmithKline PLC 26 June 2003 GLAXOSMITHKLINE RECEIVES FDA APPROVABLE LETTER FOR WELLBUTRIN XLTM EXTENDED RELEASE TABLETS Research Triangle Park, NC and London (26 June 2003) - GlaxoSmithKline plc announced today it has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the antidepressant Wellbutrin XL(TM) (bupropion hydrochloride extended-release tablets), which is under review for the treatment of major depressive disorder in patients aged 18 and older. GlaxoSmithKline is working with the FDA to clarify and resolve outstanding issues. "The approvable letter involves resolution of routine matters and consequently we remain on track for approval of Wellbutrin XL during the second half of 2003. We believe that this product will provide an important new treatment option for adults with depression," said Stan Hull, Senior Vice President, GlaxoSmithKline. GlaxoSmithKline licensed the once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001. S M Bicknell Company Secretary 26 June 2003 About GSK: 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. Under the safe harbor provisions of the US Private Securities Litigation Reform Act of 1995, GlaxoSmithKline cautions investors that any forward-looking statements or projections made by GlaxoSmithKline, including those made in this news release, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect the GlaxoSmithKline group of companies' operations are described under Risk Factors in the Operating and Financial Review and Prospects in GlaxoSmithKline's Annual Report on Form 20-F for 2002, filed with the US Securities and Exchange Commission." # # # For further information, please contact: GSK Enquiries UK Media Martin Sutton 020 8047 5502 Chris Hunter-Ward 020 8047 5502 David Mawdsley 020 8047 5502 US Media Veronica Grosshandler (919) 483 2839 Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patricia Seif (215) 751 7709 European Analyst/Investor Duncan Learmouth 020 8047 5540 Philip Thomson 020 8047 5543 Anita Kidgell 020 8047 5542 US Analyst/Investor Frank Murdolo (215) 751 7002 Tom Curry (215) 751 5419 This information is provided by RNS The company news service from the London Stock Exchange

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