FDA approves GSK’s Voltaren Arthritis Pain for over-the-counter use in the United States – GSK

First and only prescription strength NSAID gel for arthritis pain to be available OTC

Published: Warren, New Jersey, USA

GlaxoSmithKline (LSE/NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) has approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1% (NSAID)- arthritis pain reliever) as an over-the-counter (OTC) product for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults (18 years and older).With the FDA’s approval, Voltaren Arthritis Pain becomes the first and only prescription strength, nonsteroidal anti-inflammatory (NSAID) topical gel for arthritis pain available OTC 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[1] over-the-counter access to this topical treatment option.

Franck Riot, Head of R&D, GSK Consumer Healthcare said: “For the millions of people around the world living with arthritis, joint pain and stiffness are daily realities. At GSK, we are committed to improving the quality of life of these people and today’s approval is progress towards this, providing consumers in the US with increased access to an effective, proven arthritis pain relief option. Voltaren is currently the number 1 OTC topical pain relief brand globally, and we look forward to expanding its availability in the US.”

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By Jessica Yap-Chung
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