Perrigo Co. (PRGO) announced that it has received tentative approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application or ANDA for over-the-counter or OTC Ibuprofen and Diphenhydramine Citrate Tablets, 200/38 mg.
The product will be marketed under store brand labels and is comparable to Wyeth Consumer Healthcare's Advil PM tablets, 200/38 mg, indicated as a pain reliever (NSAID)/nighttime sleep-aid. Estimated brand sales for the product for the last 12 months ending September 28, 2008 were $70 million.
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