HAYWARD, Calif., May 14, 2010 (BUSINESS WIRE) --Impax Laboratories, Inc.(NASDAQ: IPXL) today confirmed
that the U.S. Food and Drug Administration (FDA) has granted tentative
approval of the Company's Abbreviated New Drug Application (ANDA) for
generic version of Opana(R) ER (oxymorphone hydrochloride) 5, 7.5, 10, 15,
20, 30 and 40 mg tablets. Endo Pharmaceuticals Inc. markets Opana(R) ER
for the treatment of moderate to severe pain.
According to Wolters Kluwer Health, U.S. sales of Opana(R) ER tablets were
approximately $241 million for the 12 months ended March 31, 2010.
About Impax Laboratories, Inc.
Impax Laboratories, Inc. is a technology based specialty pharmaceutical
company applying its formulation expertise and drug delivery technology
to the development of controlled-release and specialty generics in
addition to the development of branded products. Impax markets its
generic products through its Global Pharmaceuticals division and markets
its branded products through the Impax Pharmaceuticals division.
Additionally, where strategically appropriate, Impax has developed
marketing partnerships to fully leverage its technology platform. Impax
Laboratories is headquartered in Hayward, California, and has a full
range of capabilities in its Hayward and Philadelphia facilities. For
more information, please visit the Company's Web site at:www.impaxlabs.com.
"Safe Harbor" statement under the Private Securities Litigation
Reform Act of 1995:
To the extent any statements made in this news release contain
information that is not historical, these statements are forward-looking
in nature and express the beliefs and expectations of management. Such
statements are based on current expectations and involve a number of
known and unknown risks and uncertainties that could cause the Company's
future results, performance or achievements to differ significantly from
the results, performance or achievements expressed or implied by such
forward-looking statements. Such risks and uncertainties include, but
are not limited to, the effect of current economic conditions on the
Company's industry, business, financial position, results of operations
and market value of its common stock, the ability to maintain an
effective system of internal control over financial reporting,
fluctuations in revenues and operating income, reductions or loss of
business with any significant customer, the impact of competitive
pricing and products and regulatory actions on the Company's products,
the ability to sustain profitability and positive cash flows, the
ability to maintain sufficient capital to fund operations, any delays or
unanticipated expenses in connection with the operation of the Taiwan
facility, the ability to successfully develop and commercialize
pharmaceutical products, the uncertainty of patent litigation, consumer
acceptance and demand for new pharmaceutical products, the difficulty of
predicting Food and Drug Administration filings and approvals, the
inexperience of the Company in conducting clinical trials and submitting
new drug applications, reliance on key alliance and collaboration
agreements, the availability of raw materials, the ability to comply
with legal and regulatory requirements governing the healthcare
industry, the regulatory environment, exposure to product liability
claims and other risks described in the Company's periodic reports filed
with the Securities and Exchange Commission. Forward-looking statements
speak only as to the date on which they are made, and Impax undertakes
no obligation to update publicly or revise any forward-looking
statement, regardless of whether new information becomes available,
future developments occur or otherwise.
SOURCE: Impax Laboratories, Inc.
Impax Laboratories, Inc.
Mark Donohue, 215-933-3526
Sr. Director, Investor Relations and Corporate Communications
www.impaxlabs.com