The US FDA has approved two allergy-related ophthalmic drugs for nonprescription, or over-the-counter (OTC), use through a process called a prescription (Rx)-to-OTC switch.

The FDA approved 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.


“As a result of the Rx-to-OTC switch process, many products sold over-the-counter today use ingredients or dosage strengths that were available only by prescription 30 years ago,” said Karen Mahoney, M.D., acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research. “Approval of a wider range of nonprescription drugs has the potential to improve public health by increasing the types of drugs consumers can access and use that would otherwise only be available by prescription. This includes providing the millions of people that suffer with joint pain from arthritis daily over-the-counter access to another non-opioid treatment option.”

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.

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.

Pataday Twice Daily Relief was first approved by the FDA in 1996 under the name Patanol as a prescription drug and was indicated for the treatment of the signs and symptoms of allergic conjunctivitis (referring to ocular redness and itching due to allergies). Pataday – now Pataday Once Daily Relief – was first approved by the FDA in 2004 as a prescription drug and was indicated for the treatment of ocular itching associated with allergic conjunctivitis. These drugs are mast cell stabilizers, which work by preventing the release of histamine and therefore prevent or control allergic disorders. Ocular itching caused by allergens is a common ailment in the U.S., affecting millions of people. Consumers are advised to stop use and talk to their health care professional if they experience eye pain, changes in vision, increased redness of the eye, worsening of itching or itching lasting for more than 72 hours.

All three products will be marketed in the US 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.

The FDA granted the approvals of nonprescription Pataday Twice Daily Relief and Pataday Once Daily Relief to Alcon.