FDA approved the switch process ”Rx-to-OTC” from Voltaren Arthritis Pain

for the temporary relief of arthritis pain.

Voltaren Arthritis Pain is a nonsteroidal anti-inflammatory drug (NSAID) and works by reducing substances in the body that cause pain and inflammation. This product, previously referred to as Voltaren Gel 1%, was first approved by the FDA in 2007 as a prescription drug and was indicated for the relief of the pain of osteoarthritis of joints responsive to topical treatment, in particular, the joints of the hands, knees and feet. It has not been shown to work for strains, sprains, bruises or sports injuries.

Voltaren Arthritis Pain is intended for the temporary relief of joint pain due to the most common type of arthritis, osteoarthritis, which increases with age, affects millions of people in the U.S., and can generally be self-diagnosed. Arthritis is the swelling and tenderness of one or more of your joints. Symptoms of arthritis include pain, swelling, stiffness, and difficulty moving a joint.

The process of changing the status of a drug from prescription to nonprescription is called an Rx-to-OTC switch. It is usually initiated by the manufacturer of the prescription drug. For a drug to switch to nonprescription status, the data provided must demonstrate that the drug is safe and effective for use in self-medication as directed in proposed labeling. The manufacturer must show that consumers can understand how to use the drug safely and effectively without the supervision of a healthcare professional.

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