Perrigo Company Announces Final FDA Approval for OTC Famotidine Complete Chewable Tablets
Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) 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® 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 (http://www.perrigo.com/).
Note: Certain statements in this press release are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to the safe harbor created thereby. These statements relate to future events or the Company's future financial performance and involve known and unknown risks, uncertainties and other factors that may cause the actual results, levels of activity, performance or achievements of the Company or its industry to be materially different from those expressed or implied by any forward-looking statements. In some cases, forward-looking statements can be identified by terminology such as "may," "will," "could," "would," "should," "expect," "plan," "anticipate," "intend," "believe," "estimate," "predict," "potential" or other comparable terminology. The Company has based these forward-looking statements on its current expectations, assumptions, estimates and projections. While the Company believes these expectations, assumptions, estimates and projections are reasonable, such forward-looking statements are only predictions and involve known and unknown risks and uncertainties, many of which are beyond the Company's control. These and other important factors, including those discussed under "Risk Factors" in the Company's Form 10-K for the year ended June 30, 2007, as well as the Company's subsequent filings with the Securities and Exchange Commission, may cause actual results, performance or achievements to differ materially from those expressed or implied by these forward-looking statements. The forward-looking statements in this press release are made only as of the date hereof, and unless otherwise required by applicable securities laws, the Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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