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FDA Accepts Tasimelteon New Drug Application For Priority Review In The Treatment Of Non-24-Hour Disorder In The Totally Blind
Date:7/29/2013

s adverse events were deemed unrelated to study drug and the rates between tasimelteon and placebo treated patients were similar (1.6%, 1.5%).

About Vanda Pharmaceuticals Inc.
Vanda Pharmaceuticals Inc. is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders.  For more on Vanda, please visit http://www.vandapharma.com.  

Company Contact:
Jim Kelly
Senior Vice President and Chief Financial Officer
Vanda Pharmaceuticals Inc.
(202) 734-3428
jim.kelly@vandapharma.com

Media Contact:
Laney Landsman
Assistant Vice President
Makovsky
(212) 508-9643
llandsman@makovsky.com

CAUTIONARY NOTE REGARDING FORWWARD 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," "project," "target," "goal," "likely," "will," "would," and "could," or the negative of these terms 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.  Important factors that could cause actual results to differ materially from those reflected in the company's forward-looking statements include, among others: Vanda's failure to obtain, or any delay in obtaining, regulatory approval for tasimelteon for the treatment of Non-24-Hour Disorder or to comply with ongoing regulatory requirements and other factors that are described in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results
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4. Vanda Presents Data From Phase III Studies that Demonstrate Tasimelteon Restores Daily Cortisol Rhythm In Blind Patients With Non-24-Hour Disorder
5. Vanda Presents Data From Tasimelteon Phase III Studies In Non-24-Hour Disorder
6. Vanda Announces Submission To FDA Of A New Drug Application For Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
7. Vanda to Present Tasimelteon Non-24 Phase III Data at Two Medical Meetings
8. Vanda Reports Successful Completion Of Pre-NDA Meeting With FDA On Tasimelteon For The Treatment Of Non-24-Hour Disorder In The Totally Blind
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