Impax Laboratories Receives Final FDA Approval for Generic OPANA® ER Tablets
July 22 2010 - 4:30PM
Business Wire
Impax Laboratories, Inc. (NASDAQ:IPXL) today announced
that the U.S. Food and Drug Administration (FDA) has granted final
approval of the Company’s Abbreviated New Drug Application (ANDA)
for the generic version of OPANA® ER (oxymorphone hydrochloride)
Extended Release 30mg tablet. In June 2010, the Company was granted
final approval for the 5mg, 10mg, 20mg, and 40mg tablets.
As previously announced, in June 2010, the Company reached
agreement with Endo Pharmaceuticals and Penwest Pharmaceuticals to
grant the Company a license to sell a generic of OPANA® ER on Jan.
1, 2013 or earlier under certain circumstances.
The Company was the first to file a paragraph IV certification
on these strengths and will be entitled to 180 days of market
exclusivity upon product launch. Global Pharmaceuticals, Impax’s
generic division will commercialize the product on Jan. 1, 2013 or
earlier under certain circumstances.
Endo Pharmaceuticals and Penwest Pharmaceuticals manufacture and
market OPANA® ER for the treatment of moderate to severe pain.
According to Wolters Kluwer Health, U.S. sales of OPANA® ER tablets
were approximately $254 million for the 12 months ended May 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, Philadelphia and Taiwan
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; ability to timely file periodic reports required by the
Exchange Act; ability to maintain an effective system of internal
control over financial reporting; ability to sustain profitability
and positive cash flows; ability to maintain sufficient capital to
fund operations; any delays or unanticipated expenses in connection
with the construction of our Taiwan facility; ability to
successfully develop and commercialize pharmaceutical products; the
uncertainty of patent litigation; consumer acceptance and demand
for new pharmaceutical products; the impact of competitive products
and pricing; the difficulty of predicting Food and Drug
Administration filings and approvals; inexperience in conducting
clinical trials and submitting new drug applications; reliance on
key alliance agreements; the availability of raw materials; the
regulatory environment; exposure to product liability claims;
fluctuations in operating results and other risks described in our
Annual Report on Form 10-K for the year ended December 31, 2008.
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.
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