Perrigo Announces FDA Final Approval for Ranitidine 150 - Generic Equivalent to Zantac 150(R)
Published: May 16, 2011
ALLEGAN, Mich., May 16, 2011 /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 for over-the-counter (OTC) Ranitidine 150 (regular and cool mint), a generic version of Zantac 150®. We expect to launch early in our fiscal 2012.
Zantac 150 (ranitidine) is indicated for the relief of heartburn associated with acid indigestion and sour stomach and prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages. It has annual sales of approximately $110 million, as measured by Information Resources, Inc.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This approval is the first from our Allegan, Michigan facility since the Company returned to acceptable regulatory status. It is another example of Perrigo's commitment to bring new products to market. Perrigo continues to deliver on its mission to provide quality, affordable healthcare to consumers."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients (API) and pharmaceutical and medical diagnostic products. The Company is the world's largest store brand manufacturer of OTC pharmaceutical products and infant formulas. 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).
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