FDA Accepts Vanda Pharmaceuticals Iloperidone Resubmission and Sets New Action Date
20 11월 2008 - 11:02PM
PR Newswire (US)
ROCKVILLE, Md., Nov. 20 /PRNewswire-FirstCall/ -- Vanda
Pharmaceuticals Inc. (NASDAQ:VNDA), a biopharmaceutical company
focused on the development and commercialization of clinical-stage
product candidates for central nervous system disorders, reported
today that the FDA has accepted Vanda's resubmission of the
iloperidone New Drug Application (NDA). Vanda's resubmission was a
Complete Response to the not approvable action letter that the
company received on July 25, 2008. The FDA has indicated that it
has accepted the Complete Response for review and has set a new
target action date of May 6, 2009. ABOUT VANDA PHARMACEUTICALS
INC.: Vanda Pharmaceuticals Inc. is a biopharmaceutical company
focused on the development and commercialization of clinical-stage
product candidates for central nervous system disorders. For more
on Vanda Pharmaceuticals Inc., please visit
http://www.vandapharma.com/. CAUTIONARY NOTE REGARDING
FORWARD-LOOKING STATEMENTS Various statements in this release are
"forward-looking statements" under the securities laws. Words such
as, but not limited to, "believe," "expect," "anticipate,"
"estimate," "intend," "plan," "targets," "likely," "will," "would,"
and "could," and similar expressions or words, identify
forward-looking statements. Forward-looking statements are based
upon current expectations that involve risks, changes in
circumstances, assumptions and uncertainties. Vanda is at an early
stage of development and may not ever have any products that
generate significant revenue. Important factors that could cause
actual results to differ materially from those reflected in the
company's forward-looking statements include, among others: delays
in the completion of Vanda's clinical trials; a failure of Vanda's
product candidates to be demonstrably safe and effective; Vanda's
failure to obtain regulatory approval for its products or to comply
with ongoing regulatory requirements; a lack of acceptance of
Vanda's product candidates in the marketplace, or a failure to
become or remain profitable; Vanda's inability to obtain the
capital necessary to fund its research and development activities;
Vanda's failure to identify or obtain rights to new product
candidates; Vanda's failure to develop or obtain sales, marketing
and distribution resources and expertise or to otherwise manage its
growth; a loss of any of Vanda's key scientists or management
personnel; losses incurred from product liability claims made
against Vanda; a loss of rights to develop and commercialize
Vanda's products under its license and sublicense agreements and
other factors that are described in the "Risk Factors" section
(Part II, Item 1A) of Vanda's quarterly report on Form 10-Q for the
quarter ended September 30, 2008 (File No. 000-51863). In addition
to the risks described above and in Part II, Item 1A of Vanda's
quarterly report on Form 10-Q, other unknown or unpredictable
factors also could affect Vanda's results. There can be no
assurance that the actual results or developments anticipated by
Vanda will be realized or, even if substantially realized, that
they will have the expected consequences to, or effects on, Vanda.
Therefore, no assurance can be given that the outcomes stated in
such forward-looking statements and estimates will be achieved. All
written and verbal forward-looking statements attributable to Vanda
or any person acting on its behalf are expressly qualified in their
entirety by the cautionary statements contained or referred to
herein. Vanda cautions investors not to rely too heavily on the
forward-looking statements Vanda makes or that are made on its
behalf. The information in this release is provided only as of the
date of this release, and Vanda undertakes no obligation, and
specifically declines any obligation, to update or revise publicly
any forward-looking statements, whether as a result of new
information, future events or otherwise. DATASOURCE: Vanda
Pharmaceuticals Inc. CONTACT: Steven A. Shallcross, Senior Vice
President & CFO of Vanda Pharmaceuticals Inc., +1-240-599-4500,
Web site: http://www.vandapharma.com/
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