Perrigo Company plc issued the following announcement on May 21.
Perrigo Company plc (NYSE; TASE: PRGO) announced its partner received final approval from the U.S. Food and Drug Administration for its AB rated Abbreviated New Drug Application (ANDA) referencing Voltaren® Gel, 1% (diclofenac sodium topical gel, 1%). Perrigo will acquire full ownership of the ANDA under a pre-existing arrangement with its partner within 30 days. The Company anticipates launching this product within the next two months.
Annual market sales for Voltaren® Gel, 1% for the 12 months ending March 2019 were approximately $350 million as measured by IQVIA™.
Perrigo will manufacture diclofenac sodium topical gel 1% in its plant in Israel. The product was developed through its partnership with Capstone Development Solutions, a company of Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry.
Perrigo Executive Vice President and President Rx Pharmaceuticals Sharon Kochan stated, "This is our fifth extended topical ANDA approval in 2019 which demonstrates our commitment to delivering high quality affordable extended topical products for patients in important categories. Our strategic partnership with Water Street enables us to accelerate this commitment and lower the cost of healthcare for consumers."
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.
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