FDA Approves Store Brand Equivalent of Voltaren
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The FDA has approved an abbreviated new drug application from Perrigo for an over-the-counter store brand equivalent of Voltaren, according to a company press release.
The announcement follows the FDA’s approval last month of Voltaren Arthritis Pain (diclofenac sodium topical gel 1%, GlaxoSmithKline) for nonprescription, over-the-counter use. An NSAID previously available only with a prescription, it is intended for the temporary relief of joint pain due to osteoarthritis.
“We are pleased when the arthritis community has increased access to proven safe and effective medications in generic form,” Seth D. Ginsberg, president and co-founder of nonprofits CreakyJoints and the Global Healthy Living Foundation, told Healio Rheumatology. “Often, brands that are sold under retailer’s names are less expensive, which is good news for patients and their families.”
According to Perrigo, their product is expected to launch later this year, and will be marketed under retailers’ store brand labels.
The FDA changed Voltaren’s status through its Rx-to-OTC switch after data showed that the drug was safe and effective for self-medication use as directed in proposed labeling. Additionally, the process requires the manufacturer to demonstrated that patients can understand how to use the drug safely and effectively without the professional supervision.
The drug was initially approved by the FDA in 2007 for the relief of the pain of OA of joints responsive to topical treatment, specifically joints in the hands, knees and feet. It has not been demonstrated to work for strains, sprains, bruises or sports injuries.
“This product approval and upcoming launch demonstrates the power and versatility of Perrigo's OTC self-care platform,” Murray S. Kessler, president and CEO of Perrigo, said in the release. “The exceptional expertise demonstrated by our regulatory affairs team was evidenced through their impressive execution and record time in filing our submission and ultimately receiving approval. Our ability to successfully drive Rx-to-OTC switches differentiates Perrigo in the marketplace and is a perfect example of the Perrigo Advantage.” – by Jason Laday