ALLEGAN, Mich., Jan. 23, 2012 /PRNewswire/ -- Perrigo Company
(Nasdaq: PRGO;TASE) announced that it has filed with the U.S. Food
and Drug Administration (FDA) an Abbreviated New Drug Application
(ANDA) for azelastine hydrochloride nasal spray (0.15%) and has
notified Meda Pharmaceuticals, Inc., the owner of the New Drug
Application (NDA) of its filing. The ANDA filing involved
contributions from both Perrigo and Impax Laboratories, Inc.
(Nasdaq: IPXL), who will share costs and benefits of this
project.
On January 19, 2012, Meda
Pharmaceuticals filed suit against Perrigo in the United States
District Court for the District of New
Jersey, alleging patent infringement. This action
formally initiates the process under the Hatch-Waxman
Act.
Astepro® Nasal Spray is a prescription medicine for people 12
years of age and older and is approved to treat nasal symptoms
caused by seasonal allergies or environmental irritants. Annual
sales were approximately $114 million
annually, as measured by Wolters Kluwer Health.
Perrigo's Chairman and CEO Joseph C.
Papa stated, "This filing is another example of our
investment in new products and expansion of our extended topical
product portfolio. We are pleased to partner with Impax on this
important product opportunity. As always, Perrigo is committed to
making quality healthcare more affordable for our
customers."
Impax's President and CEO Larry
Hsu, P.h.D. stated, "We are excited to collaborate with
Perrigo on this product as we continue to execute our strategy of
diversifying our product base."
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