FDA approves GSK’s Advil Dual Action with Acetaminophen for over-the-counter use in the United States

Issued: Warren, US

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.

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.