FDA approves three drugs for counter use through Rx-to-OTC process

The U.S. FDA (Food and Drug Administration) has reportedly approved three drugs as an over-the-counter product; GlaxoSmithKline's Voltaren Arthritis Pain and Alcon’s two allergy-related drugs. As per sources, the agency has switched the status of these three drugs from prescription-based products to over the counter use products through Rx-to-OTC process.

The switch, which is usually initiated by the manufacturer, would come with a lesser cost for the medications, but companies hope to make up for it with larger volume as patients can directly get these drugs off the shelf without a doctor's prescription. 

Over the years, several allergies, heartburn, and pain drugs have made the switch after the FDA confirmed their safety standards.

Karen Mahoney, M.D.,  Deputy Director, Office of Nonprescription Drugs, FDA Center for Drug Evaluation and Research, said that authorization of a broader range of nonprescription drugs has the potential to enhance public health by increasing the types of drugs consumers can use which would otherwise only be obtainable with prescription.

For the record, Voltaren Arthritis Pain was initially authorized by the FDA as a prescription drug in 2007 to alleviate pain for osteoarthritis patients. The drug is the NSAID (a nonsteroidal anti-inflammatory drug) in a similar class as ibuprofen, though it's a topical formulation used for achy joints. The drug will continue to be approved for osteoarthritis but not for sprains, strains, and bruises that the other NSAIDs are utilized to treat.

Meanwhile, Alcon convinced the agency to switch two eye-drop medications which treat red eyes and itching caused due to allergies. Patanol, which was initially authorized in 1996, will now be called Pataday Twice Daily Relief. Pataday, which was originally authorized in 2004, will now be referred to as Pataday Once Daily Relief. The drugs have a similar active ingredient, antihistamine olopatadine, however, the once-a-day formation is a superior strength than the twice-daily formulation.

Source Credit - https://www.nasdaq.com/articles/fda-approves-3-drugs-for-the-switch-from-prescription-to-over-the-counter-2020-02-17