FDA switches 3 drugs from prescription to OTC use

FDA approved three drugs for over-the-counter (OTC) use via a prescription-to-OTC switch.

The three drugs, which will no longer be available by prescription, are: diclofenac sodium topical gel, 1% (Voltaren Arthritis Pain, GlaxoSmithKline), for the temporary relief of arthritis pain; olopatadine HCl ophthalmic solution/drops, 0.1% (Pataday Twice Daily Relief, Alcon), for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander; and olopatadine HCl ophthalmic solution/drops, 0.2% (Pataday Once Daily Relief, Alcon).

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“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,” says Karen Mahoney, MD, acting deputy director of the Office of Nonprescription Drugs in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA.

“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,” Mahoney adds.

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Voltaren Arthritis Pain, a nonsteroidal anti-inflammatory drug (NSAID), was first approved by the FDA in 2007. It is intended for temporary relief of osteoarthritis of joints responsive to topical treatment, in particular, the joints of the hands, knees and feet.

Pataday Twice Daily Relief was first approved by FDA in 1996 under the name Patanol and was indicated for the treatment of the signs and symptoms of allergic conjunctivitis.

Pataday – now Pataday Once Daily Relief – was first approved by FDA in 2004 as a prescription drug and was indicated for the treatment of ocular itching associated with allergic conjunctivitis.

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