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

First combination of ibuprofen and acetaminophen for pain relief to be available OTC in 2020Issued: Warren, USGlaxoSmithKline (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 fi rst-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 wer...
Source: Dental Technology Blog - Category: Dentistry Source Type: news