Perrigo Company Announces Final FDA Approval for OTC Famotidine Complete Chewab... ( ALLEGAN Mich. Feb. 12 /- Perrigo ...)

Perrigo Company Announces Final FDA Approval for OTC Famotidine Complete Chewable Tablets

Date:2/12/2008

ALLEGAN, Mich., Feb. 12 /PRNewswire-FirstCall/ -- Perrigo Company (Nasdaq: PRGO; TASE) today announced that it has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Famotidine 10 mg, Calcium Carbonate 800 mg, and Magnesium Hydroxide 165 mg, Chewable Tablets.

The product will be marketed under store brand labels and is comparable to Johnson & Johnson - Merck Consumer Pharmaceutical's Pepcid(R) Complete, an acid reducer plus antacid medication indicated for the relief of heartburn associated with acid indigestion and sour stomach. Annual retail sales for Pepcid Complete chewable tablets are estimated to be approximately $95 million.

Perrigo's Chairman and CEO Joseph C. Papa concluded, "This final approval reflects our continuing investment in new products. As always, Perrigo is committed to making quality healthcare more affordable for our customers and drive value for our shareholders."

Perrigo was the first applicant to file a complete ANDA with a Paragraph IV certification and we expect to have marketing exclusivity. The Company expects to begin shipping the product in the third quarter of calendar 2008.

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (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. Visit Perrigo on the Internet (

SOURCE Perrigo Company
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Perrigo Company Announces Final FDA Approval for OTC Famotidine Complete Chewab...( ALLEGAN Mich. Feb. 12 /- Perrigo ...),Health