GlaxoSmithKline : FDA approves GSK's Voltaren Arthritis Pain for over-the-counter use in the United States
Voltaren Gel, which GSKCH owns the rights to, is currently only available with a prescription in the US. Today's OTC approval of Voltaren Arthritis Pain will provide the nearly 30 million Americans with osteoarthritis[i] over-the-counter access to this topical treatment option.
Franck Riot, Head of R&D,
In addition, the
The submission in support of today's approval of Voltaren Arthritis Pain was based on clinical data in hand and knee OA supporting the original prescription approval. The data demonstrated a consistent and appreciable onset of pain relief beginning as early as week 1 (as evidenced by appreciable improvements in pain symptoms across multiple pre-specified endpoints).
About Voltaren Arthritis Pain
The active ingredient in Voltaren Arthritis Pain, diclofenac sodium, is an effective medicine that is clinically proven to relieve joint pain due to arthritis. Voltaren Arthritis Pain penetrates through the skin at the application site to deliver arthritis pain relief. Voltaren Arthritis Pain offers consumers who suffer from OA an alternative option to oral analgesics. It targets pain directly at the site and the amount of diclofenac sodium that is systemically absorbed from Voltaren Arthritis Pain is on average 6% of the systemic exposure from an oral form of diclofenac sodium. GSK anticipates Voltaren Arthritis Pain will be available on US shelves in Spring 2020.
Osteoarthritis (OA) is the most common form of arthritis. OA occurs when the cartilage between joints begins to break down and wear away, resulting in joint pain and stiffness. OA occurs more frequently with age, and the pain can gradually worsen over time. The most common symptoms associated with OA include joint pain, stiffness, and decreased range of motion.
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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
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