GSK’s Voltaren Gel gets Rx-to-OTC switch approval

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GSK’s Voltaren Gel gets Rx-to-OTC switch approval

By David Salazar - 02/18/2020

GSK is set to bring a new Rx-to-OTC switch product to market. The company on Monday received approval from the Food and Drug Administration for Voltaren Arthritis Pain as an OTC product to temporarily relieve arthritis pain in the hand, wrist, elbow, foot, ankle or knee. The product is the first and only nonsteroidal anti-inflammatory topical gel available OTC in the United States, the company said. 

"For the millions of people around the world living with arthritis, joint pain and stiffness are daily realities,” said Franck Riot, head of research and development at GSK Consumer Healthcare. “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 United States with increased access to an effective, proven arthritis pain relief option. Voltaren is currently the No. 1 OTC topical pain relief brand globally, and we look forward to expanding its availability in the United States. 

Up till now, Voltaren Gel had only been available with a prescription. GSK Consumer Healthcare said the approved switch will offer nearly 30 million Americans with osteoarthritis an OTC option to treat pain associated with their condition. 

The approval comes as the Osteoarthritis Research Society International recently updated and expanded its guidelines for nonsurgical management of osteoarthritis, recommending topical NSAIDs for individuals with osteoarthritis in the knee. 

Voltaren Arthritis Pain wasn’t the only Rx-to-OTC switch product approved. The FDA also approved two formulations of Alcon’s Pataday as OTC treatments.