Shares in Perrigo Company (Nasdaq:PRGO; TASE:PRGO) rose 10% on the Tel Aviv Stock Exchange (TASE) today as it reported tentative FDA approval for its over-the-counter ibuprofen tablets.
Perrigo announced that it has received tentative approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application for over-the-counter Ibuprofen and Diphenhydramine Citrate Tablets, 200/38 mg.
The product is comparable to Wyeth Consumer Healthcare's Advil PM tablets, indicated as a pain reliever and nighttime sleep-aid. Estimated brand sales for the product for the last 12 months ending September 28, 2008 were $70 million.
Perrigo will market its version under store brand labels. The national brand's exclusivity ends prior to the end of the calendar year.
Perrigo chairman and CEO Joseph C. Papa said, "This is an important addition to our portfolio of products that saves the consumer of our OTC healthcare products approximately $1 billion annually when compared to the higher priced national brands."
Perrigo is the world's largest manufacturer of over the counter pharmaceutical products for the store brand market.
Perrigo's shares on Nasdaq were up over 6% in mid-day trading. Its market cap is about $2.93 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on October 29, 2008
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