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Perrigo Company (PRGO) Announces FDA Final Approval of Betamethasone Valerate Foam 0.12%


11/28/2012 8:15:51 AM

ALLEGAN, Mich., Nov. 27, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that its partner, Cobrek Pharmaceuticals, Inc., received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for betamethasone valerate foam 0.12%, the generic equivalent of Luxiq® Foam. Perrigo has manufactured the product and is preparing to commence commercial shipments on January 15, 2013, consistent with the date certain launch settlement. Cobrek was first to file, making the product eligible for 180 days of marketing exclusivity.

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

Betamethasone valerate foam 0.12% is indicated for the relief of corticosteroid-responsive skin conditions of the scalp (scalp psoriasis). Brand annual sales were approximately $40 million.

Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This is our sixth product approval using a foam dosage form, which requires specialized development and manufacturing capabilities. It is an example of the excellent partnership we have with Cobrek and we are committed to making quality healthcare more affordable for our customers and drive value for our shareholders."

From its beginnings as a packager of generic home remedies in 1887, Perrigo Company, based in Allegan, Michigan, has grown to become a leading global provider of quality, affordable healthcare products. The Company develops, manufactures and distributes over-the-counter ("OTC") and generic prescription ("Rx") pharmaceuticals, nutritional products and active pharmaceutical ingredients ("API") and is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. Perrigo's mission is to offer uncompromised "quality, affordable healthcare products", and it does so across a wide variety of product categories primarily in the United States, United Kingdom, Mexico, Israel and Australia, as well as certain other markets throughout the world, including Canada, China and Latin America. 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, 2012, 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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