Perrigo Company (NASDAQ: PRGO)(TASE: PRGO) today announced that it has filed an Abbreviated New Drug Application (ANDA) for Fluocinonide Cream 0.1%, a generic version of VANOS® Cream 0.1%. The Company believes that it is the first to file an ANDA with a Paragraph IV certification against VANOS®.
VANOS® (fluocinonide) Cream 0.1% is a corticosteroid (steroid hormone) approved to relieve the inflammation and itching caused by certain skin conditions that respond to treatment with corticosteroids in patients 12 years of age or older, and had sales of approximately $27 million for the 12 months ended April 2008, as measured by Wolters Kluwer Health.
Perrigo filed its ANDA for Fluocinonide Cream, 0.1% containing a Paragraph IV Certification with the U.S. Food & Drug Administration and notified Medicis Pharmaceutical Corporation, the listed patent holder of its filing. On June 6, 2008, Medicis filed suit alleging patent infringement in the United States District Court for the Western District of Michigan to prevent Perrigo from proceeding with the commercialization of its product. This action formally initiates the patent process under the Hatch-Waxman Act.
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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