Perrigo Announces FDA Tentative Approval for Ibuprofen PM
ALLEGAN, Mich., Oct. 29 /PRNewswire-FirstCall/ -- Perrigo Company
(Nasdaq: PRGO; TASE) today announced that it has received tentative approval
from the U.S. Food and Drug Administration for its Abbreviated New Drug
Application (ANDA) for over-the-counter (OTC) Ibuprofen and Diphenhydramine
Citrate Tablets, 200/38 mg. The national brand's exclusivity ends prior to
the end of the calendar year.
The product will be marketed under store brand labels and is comparable to
Wyeth Consumer Healthcare's Advil(R) PM tablets, 200/38 mg, indicated as a
pain reliever (NSAID)/nighttime sleep-aid. Estimated brand sales for the
product for the last 12 months ending September 28, 2008 were $70 million.
Perrigo's Chairman and CEO Joseph C. Papa stated, "This is another example
of Perrigo's investment in new products making quality healthcare more
affordable to American consumers. This is an important addition to our
portfolio of products that saves the consumer of our OTC healthcare products
approximately $1 billion annually when compared to the higher priced national
brands."
Perrigo Company is a leading global healthcare supplier that develops,
manufactures and distributes 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 28, 2008, 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.