Allegan-based Perrigo Co. (Nasdaq: PRGO) announced that it has received final approval from the United States Food and Drug Administration for its abbreviated new drug application for over-the-counter Ranitidine 150 (regular and cool mint), a generic version of Zantac 150.
The company said it planned to bring the product to market during its 2012 fiscal year.
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.
Said Perrigo chairman and CEO Joseph C. Papa: “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 develops, manufactures and distributes OTC and generic prescription pharmaceuticals, infant formulas, nutritional products, active pharmaceutical ingredients and pharmaceutical and medical diagnostic products. Perrigo 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.
More at www.perrigo.com.