Impax Receives Final FDA Approval for Generic Depakote® Extended-Release 250mg Tablets
May 06 2009 - 5:46PM
Business Wire
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed
that the U.S. Food and Drug Administration (FDA) has granted final
approval of the Company�s Abbreviated New Drug Application (ANDA)
for generic version of Depakote� (divalproex ER) 250mg
Extended-release Tablets. The Company also received tentative
approval on the 500mg tablets and expects to receive final approval
on August 3, 2009, upon expiration of the 180-day exclusivity
period. Abbott Laboratories markets Depakote� ER for the treatment
of epilepsy and bipolar disorders.
The Company expects to launch both the 250mg and 500mg tablets
on August 3, 2009, through Global Pharmaceuticals, Impax�s generic
division.
According to Wolters Kluwer Health, U.S. sales of Depakote� ER
250mg and 500mg tablets were approximately $115 million and $796
million, respectively, 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.
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