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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

of Operations" sections of Vanda's annual report on Form 10-K for the fiscal year ended December 31, 2012 which is on file with the SEC and available on the SEC's website at www.sec.gov.  In addition to the risks described above and in Vanda's annual report on Form 10-K and quarterly reports 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.

[1] U.S. Department of Health and Human Services Food and Drug Administration, "Draft Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics" June 2013. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM358301.pdf [Last accessed June 22, 2013]


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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
9. Vanda Announces Positive Results in the Second Phase III Study (RESET) of Tasimelteon for the Treatment of Non-24-Hour Disorder
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