Perrigo Company gets nods from U.S. FDA for Ibuprofen & Diphenhydramine Tablets

Perrigo Company, the world's largest manufacturer of OTC pharmaceutical products for the store brand market, has secured final nod 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.

The latest product will be marketed under store brand labels and is comparable to Wyeth Consumer Healthcare's Advil(R) PM tablets, 200/38 mg, which is indicative as a pain reliever (NSAID)/nighttime sleep-aid for backache, minor arthritis pain, or other nighttime aches.

According to a study, the brand sales for the said drug for the last 12 months ending September 28, 2008 were stand at $70 million.

Perrigo Company founded in 1887, through its subsidiaries, develops, manufactures, and distributes over-the-counter (OTC) and prescription (Rx) pharmaceuticals, nutritional products, active pharmaceutical ingredients (API), and consumer products worldwide.

Michigan-based pharmaceutical firm is expecting to begin product shipments to retailers during the first quarter of calendar year 2009.
 

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