Table of Contents
ALLEGAN, Mich. — Perrigo Co. has received final approval from the Food and Drug Administration for over-the-counter ranitidine 150.
The health care products company said Monday that the product, a generic version of Zantac 150, is slated to ship early in its 2012 fiscal year. It will come in regular and cool mint flavors.
Ranitidine is indicated for the relief of heartburn associated with acid indigestion and sour stomach, according to Perrigo. It also prevents heartburn associated with acid indigestion and sour stomach brought on by certain foods and beverages.
Based on Symphony IRI Group data, the medication has annual sales of approximately $110 million annually.
"This approval is the first from our Allegan, Mich., facility since the company returned to acceptable regulatory status," Perrigo chairman and chief executive officer Joseph Papa said in a statement. "It is another example of Perrigo’s commitment to bring new products to market."
