FDA APPROVES 3 PRESCRIPTION DRUGS FOR OVER-THE-COUNTER STATUS
by John G. Baresky on 02/21/20
Three FDA Rx to OTC Switches
Approved
The U.S. Food and Drug Administration (FDA) has approved these 3 products presently available only by prescription to be purchased without one:
- Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%)
- Approved for itching, redness of eyes triggered by allergies
- Manufactured by Alcon (NYSE: ALC)
- Pataday Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%)
- Approved for itching, redness of eyes triggered by allergies
- Manufactured by Alcon (NYSE: ALC)
- Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%)
- Approved for arthritis pain
- Manufactured by GlaxoSmithKline (NYSE: GSK)
Now available without a prescription
The FDA has specific approval processes in place to orchestrate the conversion of a prescription drug to over-the-counter (OTC) status which are rigorous and require substantial data.
A drug's safety record as a prescription therapy is heavily documented and weighs heavily in the decision of its conversion to an OTC product. It also must demonstrate its purpose and its administration can be safely followed via its label.
OTC medication not typically covered by pharmacy benefit plans
From a consumer/patient viewpoint, the switch from Rx to OTC is welcomed based on having access to the product without having to consult a medical professional for a prescription. In some cases, financial issues are triggered as the OTC formulations are typically not covered by prescription benefits and the purchaser may incur higher out-of-pocket costs.
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