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Perrigo Company (PRGO) Receives FDA Approval to Market Mini Nicotine Lozenges


10/10/2012 7:00:26 AM

ALLEGAN, Mich., Oct. 10, 2012 /PRNewswire/ -- The Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) to market over-the-counter nicotine polacrilex mini lozenge USP, 2 mg (mint flavor) and 4 mg (mint flavor).

(Logo: http://photos.prnewswire.com/prnh/20120301/DE62255LOGO )

This ANDA approval represents the first approval for mini lozenge products that will be targeted for the store brand market. The mint flavored mini lozenge will be marketed under retailer and wholesalers' store, or own brand labels and is comparable to GlaxoSmithKline's Nicorette® Mini Lozenge. The product is indicated to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. "This approval strengthens Perrigo's leading store brand position in smoking cessation products, which also includes coated and uncoated flavored gums and lozenges," said Joseph C. Papa, Perrigo's Chairman, President and Chief Executive Officer. Nicorette® Mini Lozenge is selling at an annual rate estimated at over $30 million at all retail outlets. The product is expected to begin shipping in the next 90 days.

Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic prescription (Rx) pharmaceuticals, infant formulas, nutritional products, and active pharmaceutical ingredients (API). The Company is the world's largest manufacturer of OTC pharmaceutical products and infant formulas, both for the store brand market. The Company's primary markets and locations of manufacturing and logistics operations are the United States, Israel, Mexico, the United Kingdom and Australia. 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 25, 2011, 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.

SOURCE Perrigo Company


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