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news.Healthcare products manufacturer Perrigo has revealed that its partner Dexcel Pharma Technologies has received an approvable letter for over-the-counter omeprazole delayed-release tablets for the treatment of heartburn.
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Perrigo will be Dexcel Pharma’s exclusive marketer and distributor of this product for the store brand over-the-counter (OTC) market in the US once the product has been approved for marketing by FDA.
“The approval and market introduction of a store brand OTC omeprazole product will mean that consumers will save many millions of dollars by having the choice of a lower cost 20 mg omeprazole delayed-release product available,” said Joseph Papa, Perrigo’s president and CEO.
However, Dexcel Pharma is currently facing litigation over omeprazole despite the approvable letter. There is currently one FDA approved 20mg omeprazole magnesium tablet on the OTC market, Prilosec, which is manufactured by AstraZeneca. AstraZeneca alleges that omeprazole infringes the patent of Prilosec and filed suit on May 30, 2006 to prevent Dexcel Pharma from proceeding with the commercialization of its product. The litigation is still pending.