ALLEGAN, Mich., Feb. 12 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) today announced that it has received final approval
from the U.S. Food and Drug Administration (FDA) for its Abbreviated New
Drug Application (ANDA) for over-the-counter Famotidine 10 mg, Calcium
Carbonate 800 mg, and Magnesium Hydroxide 165 mg, Chewable Tablets.
The product will be marketed under store brand labels and is comparable
to Johnson & Johnson - Merck Consumer Pharmaceutical's Pepcid(R) Complete,
an acid reducer plus antacid medication indicated for the relief of
heartburn associated with acid indigestion and sour stomach. Annual retail
sales for Pepcid Complete chewable tablets are estimated to be
approximately $95 million.
Perrigo's Chairman and CEO Joseph C. Papa concluded, "This final
approval reflects our continuing investment in new products. As always,
Perrigo is committed to making quality healthcare more affordable for our
customers and drive value for our shareholders."
Perrigo was the first applicant to file a complete ANDA with a
Paragraph IV certification and we expect to have marketing exclusivity. The
Company expects to begin shipping the product in the third quarter of
calendar 2008.
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.
SOURCE Perrigo Company
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Related links:
http://www.perrigo.com
CONTACT:
Arthur J. Shannon, Vice President, Investor
Relations and Communication, +1-269-686-1709,
ajshannon@perrigo.com, or Ernest J. Schenk, Manager, Investor
Relations and Communication, +1-269-673-9212,
eschenk@perrigo.com, both of Perrigo Company
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