Perrigo Announces Approval For Over The Counter Children's Cetirizine Oral Solution

Main Category: Pediatrics / Children's Health
Also Included In: Allergy;  Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 15 Apr 2008 - 0:00 PST

email to a friend   printer friendly   view / write opinions   rate article

Perrigo Company (Nasdaq: PRGO; TASE) announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market over-the-counter (OTC) Children's Cetirizine Hydrochloride Oral Solution (Allergy) and Children's Cetirizine Hydrochloride Oral Solution (Hives-Relief), 1mg/mL.

The product will be marketed under store brand labels and is comparable to McNeil Consumer Healthcare's Children's Zyrtec(R) Oral Solution, 1mg/mL, indicated for indoor and outdoor allergy and hives relief. According to Wolters Kluwer data, brand sales for the original prescription strength version of the product for the last 12 months ending December 2007 were approximately $80 million.

Perrigo's Chairman and CEO Joseph C. Papa stated, "This approval reflects our strategy to be first to market with the important products that make quality healthcare more affordable for our customers."

The Company expects to begin shipping the product immediately.

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.

Perrigo Company
http://www.perrigo.com