Impax Laboratories Receives Final FDA Approval for Generic FLOMAX® 0.4mg Capsules and Immediately Commences Shipment
March 02 2010 - 8:45AM
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
FLOMAX® (tamsulosin hydrochloride) 0.4mg capsules. The Company also
announced that it is commencing shipment through Global
Pharmaceuticals, Impax’s generic division.
Larry Hsu, Ph.D., president and chief
executive officer of Impax Laboratories, said: “We are pleased to
report the final approval of our ANDA and that we are immediately
commencing nation-wide shipment of our generic to FLOMAX®. This
represents a significant milestone and opportunity for our Company,
having the potential to be our largest product launch to date under
Global Pharmaceuticals label. Such an opportunity could not be
possible if it weren’t for the substantial effort from many of our
employees. Their efforts have been instrumental in preparing us to
be positioned to capture as much of the market opportunity as
possible within a limited shared exclusivity period.”
As previously announced, in October
2009, the Company reached agreement with Astellas Pharma Inc. and
Boehringer Ingelheim Pharmaceuticals, Inc. to settle U.S. patent
litigation related to the Comany’s ANDA for its generic FLOMAX®
capsules. The settlement of the litigation provided the Company
with the opportunity to launch its generic tamsulosin hydrochloride
product on March 2, 2010, prior to the expiration of pediatric
exclusivity.
Boehringer Ingelheim Pharmaceuticals,
Inc. markets FLOMAX® for the functional symptoms of benign
prostatic hyperplasia. According to Wolters Kluwer Health, U.S.
sales of FLOMAX® 0.4mg capsules were approximately $2.1 billion for
the 12 months ended December 31, 2009.
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; 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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