Labeling Update

GlaxoSmithKline PLC
18 November 2005

November 18, 2005


                 GSK STATEMENT ON FDA PROPOSED LABELING CHANGE

                            FOR SEREVENT AND ADVAI


RESEARCH TRIANGLE PARK, N.C. - GlaxoSmithKline disagrees with the FDA's proposed
product labeling changes for Serevent and Advair, because they are inconsistent
with established NIH treatment guidelines and the standard of care for asthma
treatment, which could put many patients at risk of uncontrolled asthma.

The proposed changes are a departure from recent outcomes of a July 2005 FDA
advisory committee meeting that reinforced the favorable benefit-to-risk profile
of both medicines. The advisory committee supported the use of long-acting
beta-agonists (LABA) in combination with inhaled corticosteroids (ICS) and
proposed no new restrictions.  Since that time, there have been no new data on
the safety or efficacy about salmeterol used alone or in combination with ICS.

"Patient safety is of paramount concern to GSK which is why we disagree with the
FDA's proposed labeling changes," said Dr. Kathy Rickard, GSK Vice President
Clinical Development and Medical Affairs, respiratory medicine in the U.S.  "
These proposed labeling changes would reserve the most effective asthma
treatment - the combination of inhaled corticosteroids and long-acting beta
agonists - until after a patient has failed on other treatment options and
therefore may be at risk for severe outcomes, such as exacerbations and
potentially death."

GSK believes sufficient safety information about these medicines is already in
the labels to help guide physicians about their appropriate use.  However, we
will work with FDA to address the differences of opinion about how best to
communicate the benefit risk profile of these medicines for optimal patient
care.

The current labeling of Advair is consistent with asthma treatment guidelines
established by the NIH and supported by GSK.  These guidelines position ICS and
LABA as first-line therapy for moderate to severe persistent asthma, and are
supported by a significant body of evidence.

Asthma is a chronic condition that affects 20 million Americans, causing about
5,000 deaths each year. The risk of uncontrolled asthma is significant and could
cause life-threatening situations requiring emergency room visits,
hospitalization and even causing death.  African Americans and Hispanics are
three to five times more affected by asthma in the U.S.

GSK has confidence in the proven safety profile of Advair and Serevent when
these products are used appropriately and in line with national treatment
guidelines.  There have been 81.9 million prescriptions filled to date in the
U.S. for Advair alone.

GlaxoSmithKline is committed to the appropriate use of its medicines and
communicating safety information about its products.  GSK has worked diligently
to ensure physicians have the latest information about Serevent and Advair,
which are among the most studied asthma medicines worldwide and have benefited
millions of patients.

About Serevent:

Serevent Diskus is indicated for long-term twice-daily (morning and evening)
administration in the maintenance treatment of asthma and in the prevention of
bronchospasm in patients 4 years of age and older with reversible obstructive
airway disease, including patients with symptoms of nocturnal asthma, who
require regular treatment with inhaled, short-acting beta2-agonist.  It is not
indicated for patients whose asthma can be managed by occasional use of inhaled,
short-acting beta2-agonists.

About Advair:

Advair Diskus is indicated for the long-term, twice-daily, maintenance treatment
of asthma in patients 4 years of age and older.  Advair Diskus is NOT indicated
for the relief of acute bronchospasm.

S M Bicknell
Company Secretary
18 November 2005

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.

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