Impax Receives FDA Approval for Generic Precose Tablets, 25 mg, 50 mg and 100 mg
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HAYWARD, Calif.--(Business Wire)--
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and
Drug Administration (FDA) has granted approval of the Company`s Abbreviated New
Drug Application (ANDA) for generic versions of Precose Tablets (acarbose), 25
mg, 50 mg and 100 mg strengths. Precose, a Bayer HealthCare Pharmaceuticals
product, is used in the management of type two diabetes mellitus.
The Company expects to launch all strengths in the fourth quarter of 2009,
through Global Pharmaceuticals, Impax`s generic division.
According to Wolters Kluwer Health, U.S. generic and brand sales for Acarbose 25
mg, 50 mg and 100 mg tablets were approximately $32 million for the 12 months
ended March 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 Impax`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 ("FDA") 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 detailed from time to time in
our filings 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.
Impax Laboratories, Inc.
Company Contacts:
Mark Donohue, Sr. Director Investor Relations
(215) 933-3526
www.impaxlabs.com
Copyright Business Wire 2009
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