Perrigo Company plc issued the following announcement on April 6.
Perrigo 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 1%. 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."
About Perrigo
Perrigo Company plc (NYSE; TASE: PRGO) is dedicated to making lives better by bringing "Quality, Affordable Self-Care Products™" that consumers trust everywhere they are sold. The Company is a leading provider of over-the-counter health and wellness solutions that enhance individual well-being by empowering consumers to proactively prevent or treat conditions that can be self-managed. Visit Perrigo online at http://www.perrigo.com.
Original source can be found here.
