ALLEGAN, Mich., June 27, 2012 /PRNewswire/ -- Perrigo Company (Nasdaq: PRGO;TASE) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application (ANDA) for clindamycin phosphate and benzoyl peroxide 1.2% / 5% topical gel, the generic equivalent of Duac® Gel. Perrigo acquired the ANDA in 2009, transferred production to a Perrigo manufacturing facility, and submitted an amendment to the ANDA, which was the first submission with a paragraph IV certification, Perrigo may be entitled to 180-days of marketing exclusivity and FDA has deferred determining Perrigo's exclusivity period until there is another ANDA in condition for approval. Patent litigation for this product was dismissed with prejudice in 2009. Perrigo has commenced shipment of the product.
Duac® Gel (clindamycin phosphate and benzoyl peroxide 1.2% / 5% gel) is indicated for the topical treatment of inflammatory acne vulgaris. Annual sales were approximately $130 million, as measured by Wolters Kluwer Health.
Perrigo's Chairman, President and CEO Joseph C. Papa stated, "This approval is a testament to our continued commitment to bring new products first to market, our leadership in the topical space, and the diligent execution of our team. We're pleased to bring this new topical product to market and continue to focus on our mission of making healthcare more accessible and affordable for consumers."
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