FDA Approves OTC Switch of Diclofenac Gel, Olopatadine Eye Drops

Diclofenac sodium topical gel and olopatadine HCl ophthalmic drops will soon be available over-the-counter (OTC) after the the Food and Drug Administration (FDA) switched the status of these products from prescription to nonprescription.

Diclofenac topical gel will be marketed under the brand name Voltaren Arthritis Pain (GlaxoSmithKline) and is indicated for the temporary relief of arthritis pain in the hand, wrist, elbow, foot, ankle or knee in adults ≥18 years old. The OTC formulation is the same as the prescription strength (10mg of diclofenac sodium per gram or 1%). It is expected to be available in spring 2020. 

Olopatadine HCl ophthalmic solution will be available OTC in 2 strengths: 0.1% (Pataday Twice Daily Relief; Alcon) and 0.2% (Pataday Once Daily Relief; Alcon). Both are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair and dander for ages 2 and older. Pataday Twice Daily Relief is also indicated for the temporary relief of red eyes. The products will be available starting March 2, 2020.

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

For more information visit fda.gov.