Regulatory Approval

GlaxoSmithKline PLC 28 August 2003 U.S. FDA APPROVES WELLBUTRIN XL (bupropion hydrochloride extended-release tablets) Philadelphia, PA and London, 28th August 2003 - GlaxoSmithKline plc (LSE and NYSE:GSK) announced today that Wellbutrin XL(TM) (bupropion hydrochloride extended-release tablets) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of major depressive disorder in patients 18 years and older. Wellbutrin XL is the first once-daily norepinephrine and dopamine reuptake inhibitor (NDRI) for the treatment of depression. GlaxoSmithKline expects Wellbutrin XL to be available in pharmacies by mid-September. Depressive illness affects approximately 14 million adults or 6.6 percent of the U.S. population in a given year. In the U.S. there is more than a 16 percent chance for an adult to develop major depressive disorder in his or her lifetime. Nearly two-thirds of people fail to get help for their depression, yet treatment can alleviate symptoms in more than 80 percent of cases. "Wellbutrin XL builds on a strong foundation. Through the first half of 2003, our twice-daily formulation, Wellbutrin SR(R), has remained the number one prescribed antidepressant among U.S. psychiatrists," said Chris Viehbacher, President, US Pharmaceuticals, GlaxoSmithKline. "Yet we know that for many doctors twice-daily dosing is a major prescribing barrier. We are confident that the convenient once-daily dosing of Wellbutrin XL will be a welcome improvement for patients coping with depressive illness and for the physicians who are treating them." Wellbutrin XL tablets have a two-layered coating designed to release drug slowly in the body. GlaxoSmithKline licensed the once-daily formulation of bupropion hydrochloride from Biovail Corporation in October 2001. S M Bicknell Company Secretary 28th August 2003 About GlaxoSmithKline: 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. Enquiries: UK Media enquiries: Martin Sutton (020) 8047 5502 David Mawdsley (020) 8047 5502 Chris Hunter-Ward (020) 8047 5502 US Media enquiries: Nancy Pekarek (215) 751 7709 Mary Anne Rhyne (919) 483 2839 Patty Seif (215) 751 7709 European Analyst/Investor enquiries: Duncan Learmouth (020) 8047 5540 Anita Kidgell (020) 8047 5542 Philip Thomson (020) 8047 5543 US Analyst/Investor enquiries: 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

Companies

GSK (GSK)
UK 100

Latest directors dealings