WEDNESDAY, Feb. 19, 2020 — The U.S. Food and Drug Administration approved three drugs for nonprescription, over-the-counter use — Voltaren Arthritis Pain (diclofenac sodium topical gel, 1 percent), Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1 percent), and Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2 percent) — the agency announced Friday.
All three products will now be marketed as nonprescription drugs and will no longer be available as prescription drugs. For the drugs to switch to nonprescription status, data had to demonstrate the drugs’ safety and efficacy for self-medication use as directed in proposed labeling, according to the FDA.
The nonsteroidal anti-inflammatory drug Voltaren Arthritis Pain, previously Voltaren Gel 1 percent, was first approved in 2007 as a prescription drug indicated to relieve pain from osteoarthritis of the joints, particularly joints of the hands, knees, and feet. The FDA noted that it may take up to seven days for Voltaren Arthritis Pain to work, and patients should stop using it if their pain does not improve in seven days or they need to use the product for more than 21 days. Diclofenac may cause severe allergic reactions, especially for people allergic to aspirin. There is also a risk for liver damage if Voltaren Arthritis Pain is used more or longer than indicated or when patients use other products containing diclofenac simultaneously.
The FDA first approved Pataday Twice Daily Relief in 1996 under the name Patanol for the treatment of allergic conjunctivitis symptoms. Pataday Once Daily Relief was approved as Pataday in 2004 as a prescription drug for the treatment of ocular itching from allergic conjunctivitis. If users of Pataday Twice Daily Relief or Pataday Once Daily Relief experience eye pain, vision changes, increased redness of the eye, worsened itching, or itching that lasts for more than 72 hours, they should stop use and contact their health care professional.
Approval of nonprescription Voltaren Arthritis Pain was granted to GlaxoSmithKline, and the approvals of Pataday Twice Daily Relief and Pataday Once Daily Relief were granted to Alcon.
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