BRIEF—FDA approves three Rx-to-OTC switches

15 February 2020

The US Food and Drug Administration on Friday approved three drugs for non-prescription, or over-the-counter (OTC), use through a process known as prescription (Rx)-to-OTC switch.

The FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain;  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 non-prescription use.

The FDA granted the approval of non-prescription Voltaren Arthritis Pain to GlaxoSmithKline and non-prescription Pataday Twice Daily Relief and Pataday Once Daily Relief to Alcon.

All three products will be marketed in the USA as non-prescription drugs and will no longer be available as prescription drugs.



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