ALLEGAN, Mich., Dec. 10 /PRNewswire-FirstCall/ -- The Perrigo Company (Nasdaq: PRGO; TASE) announced today that the U.S. Food & Drug Administration (FDA) has granted final approval to Dexcel Pharma Technologies, Ltd. for 20 mg Omeprazole delayed-release tablets. As the exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the United States, Perrigo expects to begin shipping its product during the first quarter of calendar year 2008, with full year annual sales to be in the range of $150 - $200 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "The approval from the FDA is the final regulatory step for this exclusive product launch, which we expect to be the largest product in Perrigo's 120 year history. While we are excited about the opportunity, we will obviously continue investing in research and development to add more new products to our product offering. The launch of Omeprazole is another example of Perrigo's dedication to make quality healthcare more affordable."
Based on pre-launch estimates, Perrigo's Omeprazole product is expected to contribute between $0.20 and $0.25 earnings per share in fiscal year 2008. As a result of the Omeprazole launch, full year earnings for fiscal year 2008 are expected to be in the range of $1.32 to $1.47 per share.
Prilosec OTC(R) is indicated for the treatment of frequent heartburn and had estimated current annual sales of approximately $750 million in all outlets.
Headquartered in Or Akiva, Israel, Dexcel Pharma Technologies, Ltd. is
a privately-held, international specialty pharmaceutical company which
focuses on the development, manufacture and marketing of innovative
prescription, generic prescription, and OTC
|SOURCE The Perrigo Company|
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