DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 205677/S-001
SUPPLEMENT APPROVAL
Vanda Pharmaceuticals, Inc.
Attention: Marlene Dressman, PhD
Vice President
2200 Pennsylvania Ave NW
Suite 300-E
Washington, DC 20037

Dear Dr. Dressman:
Please refer to your Supplemental New Drug Application (sNDA) dated October 7, 2014,
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for Hetlioz
(tasimelteon) 20mg capsules.
This “Prior Approval” supplemental new drug application proposes the addition of the sentence
“The absolute oral bioavailability of tasimelteon is 38.3%.” in section 12.3 of the full
prescribing information. Other minor changes included in this supplement are as follows:
1.  Replaced ™ symbol with ® symbol globally for HETLIOZ®.
2.  Correction of typo in Prescribing Information from “6.1 Clinical Trial Experience” to
“6.1 Clinical Trials Experience”.
3.  Correction of typo in Section 12.3 related to oral volume of distribution of tasimelteon at
steady state from “56 – 126 L” to “59 – 126 L”.
4.  Correction of number of subjects enrolled in Study 2, Table 2, from “20” to “10” for each
treatment group.
APPROVAL & LABELING
We have completed our review of this supplemental application. It is approved, effective on the
date of this letter, for use as recommended in the enclosed, agreed-upon labeling text.
CONTENT OF LABELING
As soon as possible, but no later than 14 days from the date of this letter, submit the content of
labeling [21 CFR 314.50(l)] in structured product labeling (SPL) format using the FDA
automated drug registration and listing system (eLIST), as described at
http://www.fda.gov/ForIndustry/DataStandards/StructuredProductLabeling/default.htm. Content
of labeling must be identical to the enclosed labeling (text for the package insert), with the
addition of any labeling changes in pending “Changes Being Effected” (CBE) supplements, as
well as annual reportable changes not included in the enclosed labeling.

Reference ID: 3672439

 NDA 205677/S-001
Page 2

Information on submitting SPL files using eList may be found in the guidance for industry titled
“SPL Standard for Content of Labeling Technical Qs and As at
http://www.fda.gov/downloads/DrugsGuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf
The SPL will be accessible from publicly available labeling repositories.
Also within 14 days, amend all pending supplemental applications that includes labeling changes
for this NDA, including CBE supplements for which FDA has not yet issued an action letter,
with the content of labeling [21 CFR 314.50(l)(1)(i)] in MS Word format, that includes the
changes approved in this supplemental application, as well as annual reportable changes and
annotate each change. To facilitate review of your submission, provide a highlighted or markedup copy that shows all changes, as well as a clean Microsoft Word version. The marked-up copy
should provide appropriate annotations, including supplement number(s) and annual report
date(s).
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
If you have any questions, call Dr. Brendan Muoio, Regulatory Project Manager, at (240) 402­
4518.
Sincerely,
{See appended electronic signature page}
Mitchell V. Mathis, MD
CAPT, USPHS
Director
Division of Psychiatry Products
Office of Drug Evaluation I
Center for Drug Evaluation and Research
ENCLOSURE:
Content of Labeling

Reference ID: 3672439

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------MITCHELL V Mathis
12/12/2014

Reference ID: 3672439