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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