FDA Approves Ibuprofen PM
Perrigo Company announced that it has received final approval from the U.S. Food and Drug Administration 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 calendar year 2009.
The product will be marketed under store brand labels and is comparable to Wyeth Consumer Healthcare's Advil(R) 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.
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 Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom.