Healthcare company Perrigo Company plc (NYSE:PRGO) said on Monday that it is the first company to receive approval from the US Food and Drug Administration for its abbreviated new drug application (ANDA) for over-the-counter (OTC) diclofenac sodium topical gel 1% for the treatment of arthritis pain, with a launch later this year.
Through its prescription (Rx)-to-OTC switch process, the US FDA approved the company's Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription or OTC use .
The company added the product will be marketed under retailer's store brand labels and will provide consumers with a high-quality, value alternative to GSK's Voltaren Arthritis Pain, which is indicated for the temporary relief of arthritis pain.
For the 12 months ending February 2020, the branded and generic prescription sales were USD250, according to IQVIA.
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