Perrigo Announces FDA Approval for the Store Brand Equivalent of Voltaren Arthritis Pain
P
errigo Company plc (NYSE: PRGO; TASE) announced that it was the first to receive approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for over-the-counter (OTC) diclofenac sodium topical gel 1pc .
On February 14, 2020, the FDA approved Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for nonprescription or OTC, use through its prescription (Rx)-to-OTC switch process.
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. Branded and generic prescription sales for the twelve months ending February 2020 were $250M according to IQVIA as this is a brand-new OTC product which Perrigo expects to launch later this year.
Perrigo President and CEO Murray S. Kessler commented, This product approval and upcoming launch demonstrates the power and versatility of Perrigo's OTC self-care platform. 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 market place and is a perfect example of the Perrigo Advantage.
✔️ Perrigo Announces FDA Approval for the Store Brand Equivalent of Voltaren Arthritis Pain
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