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
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