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Rx-to-OTC Switch Process : FDA Approves Three Drugs


The U.S. Food and Drug Administration today approved three drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch. The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain; Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander, for nonprescription use.

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.

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, 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.

All three products will be marketed in the U.S. as nonprescription drugs and will no longer be available as prescription drugs. Consumers should read and follow the Drug Facts labels for the nonprescription products. Patients who currently take prescription versions of these products and have questions about the Rx-to-OTC switch should talk to their #health #care professional.


#RxtoOTC

#health #swelling #care #stiffness #osteoarthritis #arthritis #pain

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