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Perrigo reports FDA approval for Dexcel’s OTC omeprazole

The Perrigo Company has announced that the FDA has granted final approval to Dexcel Pharma Technologies for 20mg omeprazole delayed-release tablets for the treatment of frequent heartburn.

As the exclusive marketer and distributor of this product for the store brand over-the-counter market in the US, Perrigo expects to begin shipping its product during the first quarter of calendar year 2008.

Joseph Papa, Perrigo’s chairman and CEO, said: “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 R&D 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.”