Voltaren switches to OTC status in the US

Voltaren switches to OTC status in the US

19 February 2020 - Deborah Wilkes

The US Food and Drug Administration (FDA) has switched GlaxoSmithKline’s (GSK’s) topical pain reliever Voltaren (diclofenac sodium topical gel 1%) from prescription-to-OTC status. GSK said the OTC version, called Voltaren Arthritis Pain, would be “available on US shelves in spring 2020”.

The US has been slow to switch diclofenac. Topical pain relievers containing diclofenac already have OTC status in key markets around the world.

Karen Mahoney – acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research (CDER) – said the new OTC medicine provided “another non-opioid treatment option”.

Franck Riot, head of research and development at GSK Consumer Healthcare, pointed out that Voltaren was the "number one OTC topical pain relief brand globally”. “We look forward to expanding its availability in the US,” added Riot.

Product details in the US

In the US, Voltaren Arthritis Pain will be supplied as a gel containing 1% of the non-steroidal anti-inflammatory drug (NSAID) diclofenac sodium.

GSK said Voltaren Arthritis Pain would be the “first and only prescription-strength NSAID gel for arthritis pain to be available OTC in the US”.

The FDA has approved Voltaren Arthritis Pain for the “temporary relief of arthritis pain”.

Packaging points out the gel is “clinically proven to relieve arthritis pain” and is “original prescription strength”. It highlights that treatment areas include hands, wrists, elbows, feet, ankles and knees.

The prescription version, Voltaren Gel 1%, was first approved by the FDA in 2007. The FDA said it would no longer be available.

In addition to giving OTC status to Voltaren Arthritis Pain, the FDA has switched two versions of Alcon’s Pataday (olopatadine HCl) eye drops (click here to read the News story).

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