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 Vand
|SOURCE Vanda Pharmaceuticals Inc.|
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