WARREN, N.J., Feb. 28, 2020 /PRNewswire/ -- GlaxoSmithKline
(LSE/NYSE: GSK) today announced that the U.S. Food and Drug
Administration (FDA) has approved Advil Dual Action with
Acetaminophen as an over-the-counter (OTC) product for pain relief.
The exclusive formula is now the first FDA-approved OTC combination
of ibuprofen and acetaminophen in the
United States and will be available over-the-counter
nationwide in 2020.
Franck Riot, Head of R&D, GSK Consumer Healthcare said: "For
decades, many consumers have been using ibuprofen and acetaminophen
to get the benefits of both active ingredients when safely treating
their headaches, muscle aches, backaches, arthritis and other joint
pain. Now Advil, the No. 1 selling OTC pain reliever, will offer US
consumers the first-ever alternative option -- a single, fixed-dose
combination pain reliever. As the world-leader in pain relief,
Advil Dual Action and our recently FDA-approved Voltaren Arthritis
Pain gel, demonstrates GSK's commitment to providing new safe,
effective and convenient pain relief options for consumers."
Advil Dual Action provides relief for multiple symptoms and is
the first formulation that combines ibuprofen and
acetaminophen, two powerful ingredients indicated for OTC pain
relief that work in different ways.
The submission in support of today's approval of Advil Dual
Action was based on data from seven clinical studies, three of
which were pivotal efficacy and safety studies in pain relief. The
data supports a pain relief indication and demonstrates that the
fixed-dose combination achieves superior efficacy compared to the
individual monocomponents of ibuprofen (250mg) and acetaminophen
(500mg) alone (as evidenced by appreciable improvements in acute
pain symptoms across multiple pre-specified endpoints).
About Advil Dual Action
Advil Dual Action is an
exclusive pain-fighting formula, combining ibuprofen and
acetaminophen to fight pain in two ways. Ibuprofen is a
nonsteroidal anti-inflammatory (NSAID) that targets pain at the
source, temporarily reducing the production of prostaglandins,
which cause swelling and pain signals. Acetaminophen is a pain
reliever that blocks the transmission of pain signals to the brain.
Advil Dual Action will be available over-the-counter nationwide in
2020.
GSK's commitment to pain relief
We are the world
leader in pain relief. With a portfolio of (systemic and topical)
products to relieve pain, our range brings comfort and ease to
millions. World-leading brands including Advil, Panadol and
Voltaren; and beloved local brands like Excedrin in the US and
Fenbid in China help people manage
their symptoms so they can enjoy life to the fullest.
Important safety information about Advil Dual Action
Before using the product, consumers should read the Advil Dual
Action drug facts label.
About GSK
We are a science-led global healthcare
company with a special purpose: to help people do more, feel
better, live longer. For further information please visit
www.gsk.com.
About GSK Consumer Healthcare
We are the world's
largest Consumer Healthcare company following our new joint venture
with Pfizer Consumer Healthcare. The new drug application for Advil
Dual Action was approved under the Pfizer name. We develop and
market a portfolio of consumer-preferred and expert-recommended
brands including Sensodyne, parodontax, Poligrip, Advil, Centrum
and Theraflu.
GSK
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US Media
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Analyst/Investor
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Danielle
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James
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Cautionary
statement regarding forward-looking statements
GSK cautions
investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to
risks and uncertainties that may cause actual results to differ
materially from those projected. Such factors include, but are not
limited to, those described under Item 3.D 'Principal risks and
uncertainties' in the company's Annual Report on Form 20-F for
2018.
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SOURCE GSK Consumer Healthcare