Rx-to-OTC Switches: FDA Signs Off on Three Drugs
The US Food and Drug Administration (FDA) last Friday converted three prescription drugs to over-the-counter (OTC) drugs, increasing access to the medicines, including one for arthritis pain and two for redness of the eyes and itching due to allergies.The process of such prescription drug to OTC drug switches (known as Rx-to-OTC switches) is usually initiated by the manufacturer, FDA said.
“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,” the agency said.
FDA granted one switch to GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain, which was first approved by FDA in 2007 as a prescription drug for the relief of the pain of osteoarthritis of joints. FDA explained some of the potential side effects and also cautioned that it may take up to seven days to work.
The other two switches approved were for Alcon’s Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%), which was first approved by FDA as a prescription drug in 1996, and Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%), which was first approved in 2004. Both drugs are for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander.
Back in July 2018, FDA also released draft guidance explaining two new approaches to making nonprescription drugs available in situations where information in the drug facts label is not sufficient to support OTC use.
The switches also come as FDA is preparing, pending congressional action, to convert its OTC monograph system into a user fee-based one with exclusivity for innovative OTC products.
FDA