Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for over-the-counter (OTC) Miconazole Nitrate Vaginal Cream and Suppository, a generic to Monistat® -1 Combination Pack. Perrigo expects to begin shipping immediately.
Monistat® -1 has annual retail sales of approximately $90 million dollars. This OTC product is indicated for the treatment of vaginal yeast infections and for the relief of external itching and irritation they cause. Perrigo was the first to file an ANDA containing a Paragraph IV certification, and the resulting patent litigation filed by Johnson & Johnson was previously dismissed. Perrigo's approval includes 180 days of generic marketing exclusivity.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This is another example of Perrigo's commitment to innovation by challenging brand patents and bringing new products to market. These innovations help save OTC healthcare consumers more than an estimated $1 billion annually."
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes OTC and generic 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 and logistics operations are the United States, Australia, 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 27, 2009, 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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Web Site: http://www.perrigo.com/