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news.Perrigo Company, a provider of prescription pharmaceuticals, has received tentative approval from the FDA for its abbreviated new drug application for over-the-counter Ibuprofen and diphenhydramine citrate tablets, 200/38mg. The national brand's exclusivity ends prior to the end of 2008.
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The product will be marketed under store brand labels and is comparable to Wyeth consumer healthcare’s Advil PM tablets, 200/38mg, indicated as a pain reliever or nighttime sleep-aid.
Joseph Papa, chairman and CEO of Perrigo, said: “This is another example of Perrigo’s investment in new products making quality healthcare more affordable to American consumers.
“This is an important addition to our portfolio of products that saves the consumer of our over-the-counter healthcare products approximately $1 billion annually when compared to the higher priced national brands.”