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
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