ALLEGAN, Mich., Mar. 6 /PRNewswire-FirstCall/ -- Perrigo Company today announced that its partner, Teva Pharmaceutical Industries Ltd. , has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for over-the-counter Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride Extended-Release Tablets, 5 mg/120 mg.
The product will be marketed by Perrigo under store brand labels and is comparable to McNeil Consumer Healthcare’s recently launched Zyrtec-D(R) Extended-Release Tablets, indicated for 12 hour relief of indoor and outdoor allergy symptoms and nasal congestion. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the 12 months ending December 2007 were approximately $190 million.
Perrigo’s Chairman and CEO Joseph C. Papa stated, “This approval and marketing agreement reflect 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.”
The Company expects to begin shipping the product in the next 90 days.
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.
CONTACT: Arthur J. Shannon, Vice President, +1-269-686-1709,
ajshannon@perrigo.com, or Ernest J. Schenk, Manager, +1-269-673-9212,
eschenk@perrigo.com, both of Investor Relations and Communication, Perrigo
Company
Web site: http://www.perrigo.com//
