FDA approves Pataday eye allergy products for OTC use
Alcon’s Pataday Once Daily Relief and Pataday Twice Daily Relief products, both designed to temporarily relieve ocular itching due to pollen and other allergens, received approval from the FDA for over-the-counter use.
“We saw a wave of antihistamines receive FDA approval to move from Rx to OTC status in the early 2000s, including oral drugs like Claritin [loratadine, Bayer] and Allegra [fexofenadine HCl, Sanofi] and topical ophthalmic drops like Zaditor [ketotifen fumarate, Alcon],” Kerry Giedd, OD, MS, FAAO, told Primary Care Optometry News.
“Patients and health care providers, overall, have greatly benefited from the ease of access and symptomatic relief these medications have brought and the low risks they have presented as OTC options,” she added. “All these years later, we hardly recall the days when we had to write prescriptions for these drugs.”
Giedd, a PCON Editorial Board member who practices in Orlando, Fla., continued: “This latest Rx-to-OTC news brings a welcome update for allergy sufferers and their doctors with products that most would agree provide superior symptomatic relief over the existing OTC options. We assume most patients will net a reduced cost once the OTC Pataday reaches retail shelves, and doctors will net the savings of time, perhaps our most valuable asset. We — and our staff — will spend less time battling insurance companies to authorize drug coverage and we will spend less time on unnecessary office visits for minor complaints.”
Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%) and Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) will become commercially available in the U.S. beginning March 2 in all major drug, food and mass market retailers, Alcon said in a press release.
The FDA also announced the approval of an Rx-to-OTC switch for Voltaren Arthritis Pain (diclofenac sodium topical gel 1%, GlaxoSmithKline) for the temporary relief of arthritis pain.
“All three products will be marketed in the U.S. as nonprescription drugs and will no longer be available as prescription drugs,” the FDA noted in the announcement. “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.”