Perrigo Gets FDA Final Approval for Zantac 150 Generic Equivalent

May 17, 2011

Perrigo Co. has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter Ranitidine, a generic version of Zantac 150.

The company said it expects to launch the heartburn medication, in regular and cool mint, in early fiscal 2012.

Zantac 150 (ranitidine) has annual sales of approximately $110 million, according to data provided by Symphony IRI Group.

“This approval is the first from our Allegan, Michigan facility since the company returned to acceptable regulatory status,” said Perrigo’s Chairman and CEO Joseph C. Papa. “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.”

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