Three Prescription Drugs Get OTC Approval Leave a comment


(RxWiki News) From prescription to over-the-counter — the US Food and Drug Administration (FDA) has approved the switch for three medications.

These are the medications that will now be available over the counter (OTC):

  • Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) – This gel is used to relieve pain from arthritis.
  • Pataday Once Daily Relief and Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1% and 0.2%) – These eye drops are used to treat itchy eyes due to pollen, ragweed, grass, and animal hair or dander.

That means these medications can now be purchased without a prescription.

In order for a drug to go from prescription to OTC, the manufacturer of the medication must initiate the process. The data must show that the drug is safe and effective when used at home, following the medication label and without being supervised by a doctor.

Now that they have been approved as OTC drugs, these medications will no longer be available by prescription, the FDA noted.

The FDA originally approved Voltaren in 2007 to provide relief from pain due to osteoarthritis — specifically joint pain in the feet, hands and knees. This medication does not provide pain relief right away. In fact, it may take up to seven days to work. This drug is not approved to treat pain due to bruises, strains, sprains or sports injuries.

If arthritis pain does not get better after seven days or if you need to use the gel for more than 21 days, stop use and seek immediate medical attention. There is a risk of liver damage if this gel is used longer than recommended or when used with other products containing diclofenac.

The FDA approved Pataday Twice Daily Relief eye drops in 1996 under the name Patanol. Pataday Once Daily Relief was first approved by the FDA in 2004 under the name Pataday.

If you experience worsening of itching, itching that lasts more than three days, eye pain, changes in vision or more eye redness when using these eye drops, stop use and speak with your health care provider.

Follow the instructions on the drug labels to ensure safe use, the FDA recommended. If you have any questions about these medications or how to use them, speak with your health care provider.

The approval of the nonprescription version of Voltaren was granted to GlaxoSmithKline plc. The nonprescription approval of Pataday Once Daily and Twice Daily was granted to Alcon.

Written by Anyssa Garza, PharmD, BCMAS



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