FDA Approves Three Prescription Drugs for Over-the-Counter Use

By Zhang Suxing

Recently, the U.S. FDA approved the switch of three drugs from prescription (Rx) to over-the-counter (OTC) status.

The three medications are GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%), used for the temporary relief of arthritis pain; and Alcon’s Pataday Twice Daily Relief (olopatadine hydrochloride ophthalmic solution, 0.1%) and Pataday Once Daily Relief (olopatadine hydrochloride ophthalmic solution, 0.2%), used for the temporary relief of itchy and red eyes caused by pollen, ragweed, animal hair, or dander.

These three products will be sold as over-the-counter (OTC) drugs in the United States going forward. Consumers should read and follow the drug labels for OTC medications. Patients currently using the prescription versions of these products should consult their healthcare providers if they have questions about the transition from prescription (Rx) to over-the-counter (OTC) status.

The process of switching a drug from prescription to over-the-counter status is known as Rx-to-OTC switch. It is typically initiated by the manufacturer of the prescription drug. To facilitate the switch to over-the-counter status, the manufacturer must provide data demonstrating that the drug is safe and effective for self-use by patients in accordance with label instructions. The manufacturer must also prove that consumers can understand how to use the drug safely and effectively without supervision by healthcare professionals.

The FDA believes that approving a broader range of over-the-counter (OTC) drugs may improve public health by increasing the variety of medications available for consumer access and use—those previously accessible only by prescription.