Perrigo Receives FDA Nod For OTC Famotidine Complete Chewable Tablets

(RTTNews) - Perrigo Co. (PRGO | news | PowerRating | PR Charts ), a developer of over-the-counter and prescription pharmaceuticals, on Tuesday said it has received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for over-the-counter Famotidine 10 mg, Calcium Carbonate 800 mg and Magnesium Hydroxide 165 mg, chewable tablets.

Allegan, Michigan-based Perrigo said the product would be marketed under store brand labels and is comparable to Johnson & Johnson - Merck Consumer Pharmaceutical's Pepcid Complete, which is 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 about $95 million.

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

According to Perrigo Chairman and CEO Joseph Papa, "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."

PRGO is currently trading at $35.88, down $0.07 or 0.19%, on 869,479 shares.

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