FDA Approves Three Drugs for OTC Use

Last week, the FDA approved three medications for over-the-counter (OTC) use through a process called Rx-to-OTC switch. This means the medications can be purchased without a prescription. The Rx-to-OTC switch process is typically initiated by the manufacturer of the prescription medication. For this Rx-to-OTC switch to be approved by the FDA, the manufacturer must show that the medication can be used safely and effectively by a consumer without supervision of a healthcare professional. This includes approval of proposed labeling for the products.  The approved FDA medications are Voltaren Arthritis Pain, Pataday Once Daily Relief and Pataday Twice Daily Relief.

The prescription product Voltaren Gel 1% was first approved by the FDA in 2007 with an indication for the relief of osteoarthritis pain of joints amenable to topical therapy, such as ankle, elbow, foot, hand, knee, and wrist. Voltaren Gel 1% is currently available as a generic prescription product, diclofenac sodium topical gel 1%.  The approved OTC item will be marketed as Voltaren Arthritis Pain and will be the same strength as the current prescription product.

Pataday Once Daily Relief (olopatadine HCL ophthalmic solution/drops, 0.2%) was approved as Pataday in 2004 for the treatment of ocular itching associated with allergic conjunctivitis.

Pataday Twice Daily Relief (olopatadine HCL ophthalmic solution/drops, 0.1%) was first approved by the FDA as the prescription product Patanol in 1996 for the treatment of allergic conjunctivitis which presents as redness and itching of the eyes.

Both Pataday OTC products are indicated for the temporary relief of itchy eyes due to pollen, ragweed, grass, animal hair or dander.

All three medications will be marketed as nonprescription drugs within the U.S. and will no longer be available as prescription drugs. Those who currently take prescription versions of these medications and have questions about the Rx-to-OTC switch, should speak with their health care provider.

For more information regarding these FDA approvals, visit the FDA website at: https://www.fda.gov/news-events/press-announcements/fda-approves-three-drugs-nonprescription-use-through-rx-otc-switch-process