DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
Silver Spring MD 20993

NDA 205677
NDA APPROVAL
Vanda Pharmaceuticals, Inc.
2200 Pennsylvania Avenue NW
Suite 300 E
Washington, D.C. 20037
Attention:  

Paolo Baroldi, M.D., Ph.D.
Chief Medical Officer

Dear Dr. Baroldi:
Please refer to your New Drug Application (NDA) dated May 31, 2013, received May 31, 2013,
submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FDCA) for
HETLIOZ (tasimelteon) 20 mg oral Capsules.
We acknowledge receipt of your amendments dated:
June 6, 2013
June 18, 2013
June 19, 2013
July 1, 2013 (2)
July 3, 2013
July 31, 2013
August 2, 2013
August 8, 2013
August 13, 2013
August 15, 2013
August 20, 2013 (2)

August 22, 2013
August 27, 2013
August 30, 2013
September 4, 2013
September 17, 2013
September 30, 2013 (3)
October 1, 2013
October 8, 2013
October 9, 2013
October10, 2013
October 15, 2013

October 16, 2013
October 25, 2013
October 28, 2013
October 30, 2013 (3)
November 4, 2013
November 12, 2013
November 22, 2013
December 3, 2013
January 8, 2014
January 20, 2014

Please also refer to our approval letter dated January 31, 2014. That letter contained an error in
the “indications” sentence as described below:
Prior Statement: “This new drug application provides for the use of HETLIOZ, tasimelteon, 20 mg
(b) (4)
Capsules for Non-24 hour sleep-wake disorder
”

Corrected Statement: “This new drug application provides for the use of HETLIOZ, tasimelteon,
20 mg Capsules for Non-24 hour sleep-wake disorder.”
The effective approval date will remain January 31, 2014, the date of the original approval letter.
The labeling is unchanged.

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Page 2

We have completed our review of this 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 patient package insert, and
Medication Guide). Information on submitting SPL files using eLIST may be found in the
guidance for industry SPL Standard for Content of Labeling Technical Qs and As, available at
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/U
CM072392.pdf.
The SPL will be accessible via publicly available labeling repositories.
CARTON AND IMMEDIATE CONTAINER LABELS
We acknowledge your January 20, 2014, submission containing final printed carton and
container labels.
Marketing the product(s) with FPL that is not identical to the approved labeling text may render
the product misbranded and an unapproved new drug.
REQUIRED PEDIATRIC ASSESSMENTS
Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new
active ingredients, new indications, new dosage forms, new dosing regimens, or new routes of
administration are required to contain an assessment of the safety and effectiveness of the
product for the claimed indication(s) in pediatric patients unless this requirement is waived,
deferred, or inapplicable.
Because the drug product for this indication has an orphan drug designation, you are exempt
from this requirement.
PROMOTIONAL MATERIALS
You may request advisory comments on proposed introductory advertising and promotional
labeling. To do so, submit, in triplicate, a cover letter requesting advisory comments, the
proposed materials in draft or mock-up form with annotated references, and the package insert
to:

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 NDA 205677
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Food and Drug Administration 

Center for Drug Evaluation and Research 

Office of Prescription Drug Promotion 

5901-B Ammendale Road 

Beltsville, MD 20705-1266 

As required under 21 CFR 314.81(b)(3)(i), you must submit final promotional materials, and the
package insert, at the time of initial dissemination or publication, accompanied by a Form FDA
2253. Form FDA 2253 is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM083570.pdf.
Information and Instructions for completing the form can be found at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM375154.pdf. For
more information about submission of promotional materials to the Office of Prescription Drug
Promotion (OPDP), see http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm090142.htm.
REPORTING REQUIREMENTS
We remind you that you must comply with reporting requirements for an approved NDA
(21 CFR 314.80 and 314.81).
MEDWATCH-TO-MANUFACTURER PROGRAM
The MedWatch-to-Manufacturer Program provides manufacturers with copies of serious adverse
event reports that are received directly by the FDA. New molecular entities and important new
biologics qualify for inclusion for three years after approval. Your firm is eligible to receive
copies of reports for this product. To participate in the program, please see the enrollment
instructions and program description details at
http://www.fda.gov/Safety/MedWatch/HowToReport/ucm166910.htm.
POST APPROVAL FEEDBACK MEETING
New molecular entities and new biologics qualify for a post approval feedback meeting. Such
meetings are used to discuss the quality of the application and to evaluate the communication
process during drug development and marketing application review. The purpose is to learn
from successful aspects of the review process and to identify areas that could benefit from
improvement. If you would like to have such a meeting with us, call the Regulatory Project
Manager for this application.
PDUFA V APPLICANT INTERVIEW
FDA has contracted with Eastern Research Group, Inc. (ERG) to conduct an independent interim
and final assessment of the Program for Enhanced Review Transparency and Communication for
NME NDAs and Original BLAs under PDUFA V (‘the Program’). The PDUFA V Commitment
Letter states that these assessments will include interviews with applicants following FDA action
on applications reviewed in the Program. For this purpose, first-cycle actions include approvals,
complete responses, and withdrawals after filing. The purpose of the interview is to better
understand applicant experiences with the Program and its ability to improve transparency and
communication during FDA review.

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ERG will contact you to schedule a PDUFA V applicant interview and provide specifics about
the interview process. Your responses during the interview will be confidential with respect to
the FDA review team. ERG has signed a non-disclosure agreement and will not disclose any
identifying information to anyone outside their project team. They will report only anonymized
results and findings in the interim and final assessments. Members of the FDA review team will
be interviewed by ERG separately. While your participation in the interview is voluntary, your
feedback will be helpful to these assessments.
If you have any questions, call Cathleen Michaloski, Sr. Regulatory Project Manager, by email
Cathleen.michaloski@fda.hhs.gov or by phone (301) 796-1123.
Sincerely,
{See appended electronic signature page}

Ellis F. Unger, M.D.
Director
Office of Drug Evaluation I
Center for Drug Evaluation and Research

Enclosure(s):
Content of Labeling
Container Labeling

Reference ID: 3627825

 --------------------------------------------------------------------------------------------------------This is a representation of an electronic record that was signed
electronically and this page is the manifestation of the electronic
signature.
--------------------------------------------------------------------------------------------------------/s/
---------------------------------------------------ELLIS F UNGER
01/31/2014

Reference ID: 3627825