The US Food and Drug Administration approved Pataday to become OTC. It approved Pataday OTC through a process called a prescription to OTC switch. Pataday Twice Daily Relief (olopatadine HCL ophthalmic solution/drops 0.1%) is 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 opthalmic solution/drops, 0.2%) is also for nonprescription use.
For a drug to switch to nonprescription status, the data must show the drug is safe and effective for use in self-medication.
Pataday Twice Daily Relief was first approved by the FDA in 1996 under the name Patanol as a prescription drug. Pataday-now Pataday Once Daily relief, was approved by the FDA in 2004 as a prescription drug. These drugs are mast cell stabilizers and antihistamines, which work by preventing the release of histamine and therefore prevent or control allergic disease. Eye itching caused by allergies is a common ailment affecting millions of people.
There has been a trend for many allergy medications to become over the counter because its safety of use. Most nasal steroids are not OTC and are safe and effective in the first line treatment of allergic rhinoconjunctivitis.
In addition, most oral antihistamines are over the counter too. You can find Allegra, Claritin, Zyrtec and Benadryl easily in the aisles of drug stores and pharmacies.
Pataday OTC won’t be the first ocular antihistamine that is over the counter. Zaditor and Alaway (generic name Ketotifen) are both available without prescription.
Although Patanol (0.1% olopatadine) and Pataday (0.2 olopatadine) have both become OTC, another olopatadine drug has not. Pazeo (olopatadine 0.7%) remains prescription only. Pazeo with having a 0.7% concentration of olopatadine has shown in 2 clinical trials that it works better than the Pataday 0.2%, giving improved relief at 24 hours post treatment. The disadvantage of Pazeo is that it will require a prescription from a doctor, it is likely more expensive, and most health insurances will not cover it unless they have already failed many of over the counter ones (which will be Patanol OTC and Pataday OTC). But overall Pazeo with its higher concentration of olopatadine 0.7% compared to Pataday 0.2% and 0.1% works stronger. But most patients will probably respond well to the lower strength version anyhow.