Perrigo Company (Nasdaq:PRGO; TASE:PRGO) has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter (OTC) Ibuprofen and Diphenhydramine Citrate Tablets, 200/38 mg. Perrigo is expecting to begin product shipments to retailers during the first quarter of 2009.
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 are $70 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "We are obviously delighted by this latest approval, which is another example of Perrigo's continuing investments to make quality healthcare more affordable to American consumers. Investments like this one help save OTC healthcare consumers approximately $1 billion annually when compared to the higher priced national brands."
Perrigo is a global healthcare supplier that develops, manufactures and distributes OTC and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products.
In the quarter ending September 2008 Perrigo recorded revenue of $480 million, a rise of 25.5% over the corresponding quarter last year. The company posted profits of $38 million representing 40 cents per share.
Published by Globes [online], Israel business news - www.globes-online.com - on December 30, 2008
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