FDA approves new ibuprofen and diphenhydramine citrate tablets


ALLEGAN, Mich. Perrigo received final approval from the Food and Drug Administration for its abbreviated new drug application of over-the-counter ibuprofen and diphenhydramine citrate tablets, 200/38 mg, the company announced Monday.

Perrigo is expecting to begin product shipments to retailers during the first quarter of 2009.

The product is comparable to Wyeth Consumer Healthcare's Advil PM tablets, 200/38 mg, indicated as a pain reliever/nighttime sleep-aid.  Estimated brand sales for the product for the last 12 months ended Sept. 28 were $70 million, according to data provided by Perrigo.

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