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Perrigo heartburn drug wins FDA approval

Do you suffer from heartburn? Your dreams may have just been answered. Perrigo (NASDAQ: PRGO), the world's largest manufacturer of over-the-counter pharmaceutical products for the store brand market, announced that the Food & Drug Administration has granted final approval to partner Dexcel Pharma Technologies Ltd. for OTC generic heartburn tablets.

As the exclusive U.S. marketer and distributor of Omeprazole for the over-the-counter market, Perrigo said it expects to begin shipments during the first quarter, with full-year annual sales estimated between $150 million and $200 million.

While Perrigo is officially a U.S. company, Dexcel Pharma Technologies Ltd. is headquartered in Israel. This drug is poised to be the biggest drug ever for Perrigo. Perrigo's Chairman and CEO Joseph C. Papa said, "The approval from the FDA is the final regulatory step for this exclusive product launch, which we expect to be the largest product in Perrigo's 120-year history. While we are excited about the opportunity, we will obviously continue investing in research and development to add more new products to our product offering. The launch of Omeprazole is another example of Perrigo's dedication to make quality health care more affordable."

This is a huge win for the health-care supplier. The company raised guidance for 2008 to between $1.32 and $1.47 per share, between 20-25 cents higher than its previous forecast.

Perrigo has been a huge winner in 2007, and sure looks poised to continue moving upward in 2008.

Aaron Katsman is the lead Portfolio Manager and Managing Director of America Israel Investment Associates, LLC. and Senior Editor of IsraelNewsletter.com. Disclosure: Writer owns shares in PRGO and is long the stock as of 12/11/07.

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Last updated: November 14, 2009: 08:56 PM

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