Perrigo's ANDA for generic Zantac 150 receives FDA final approval to treat heartburn
Published on May 17, 2011 at 12:16 AM
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."