Perrigo Announces FDA Final Approval and Launch of Store Brand OTC Lansoprazole 15mg Capsules
ALLEGAN, Mich., May 18, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for Lansoprazole capsules (15 mg). Shipments of product to customers have already begun.
This new product for the U.S. store brand market is bioequivalent to Novartis' Prevacid® 24HR capsules (15 mg) and is indicated for the treatment of frequent heartburn, which occurs two or more days in a week. Sales for Prevacid OTC were approximately $220 million.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This is another example of Perrigo's continued leadership and commitment to bring key new products to the store brand OTC market. Perrigo continues to be focused on our mission of making quality healthcare more affordable for consumers. We are pleased to be in a position to bring this important new product to market – for our retail and wholesale customers' store brand product portfolios and to U.S. consumers, who will realize considerable savings now that they can purchase a high quality, value priced alternative to the national brand."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. Visit Perrigo on the Internet (http://www.perrigo.com).