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Voltaren Gel FDA Approval History

Last updated by Judith Stewart, BPharm on April 7, 2021.

FDA Approved: Yes (First approved October 17, 2007)
Brand name: Voltaren Gel
Generic name: diclofenac sodium
Dosage form: Topical Gel
Company: GlaxoSmithKline Consumer Healthcare LP
Treatment for: Osteoarthritis

Voltaren Gel (diclofenac sodium) is a topical non-steroidal anti-inflammatory (NSAID) medication indicated for the temporary relief of joint pain due to osteoarthritis.

On February 14, 2020 the FDA changed the status of Voltaren Gel 1% from prescription to non-prescription through a process called Rx-to-OTC switch. The new over-the-counter (OTC) product will be marketed as Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) and like the prescription product, is also indicated for for the temporary relief of joint pain due to osteoarthritis.

Development timeline for Voltaren Gel

Feb 17, 2020Approval FDA Approves GSK’s Voltaren Arthritis Pain for Over-the-Counter Use in the United States
Oct 22, 2007Approval Voltaren Gel Receives US Regulatory Approval as the First Approved Topical Prescription Treatment for Pain Associated with Osteoarthritis

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.