Perrigo Company Confirms FDA Tentative Approval for Clobetasol Propionate Emulsion Foam
ALLEGAN, Mich., Oct. 6, 2011 /PRNewswire/ — Perrigo Company (Nasdaq: PRGO;TASE) announced that it received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Clobetasol Propionate Emulsion Foam, 0.05%. Perrigo believes it is first-to-file on this product.
On July 12, 2010, Stiefel Research Australia Pty. Ltd. filed a patent infringement suit in the United States District Court for the District of Delaware to prevent Perrigo from commercializing this product. This action, which is still pending, formally initiated the process under the Hatch-Waxman Act.
The product is the AB-rated equivalent to Stiefel Laboratories’ OluxÃ‚® -E Foam, 0.05%, a topical corticosteroid indicated for the treatment of moderate to severe dermatosis of the scalp. Sales for the brand were approximately $40 million, according to Wolters Kluwer data for the twelve months ending September 2011.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This tentative approval reflects our strategy to be first to market with the important products that make quality healthcare more affordable for our customers and drive value for our shareholders, it is also another example of the excellent partnership we have with Cobrek for developing foam products which is a key product category for our Rx business.”
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