CLOSEOUT LETTER
Vanda Pharmaceuticals
MARCS-CMS 576442 —
November 21, 2018
Product:
Drugs
Recipient:
Recipient Name
Mihael H. Polymeropoulos, M.D.
Recipient Title
President and Chief Executive Officer
Vanda Pharmaceuticals
2200 Pennsylvania Ave NW, Suite 300E
Washington
,
DC
20037
United States
Issuing Office:
Office of Prescription Drug Promotion
5901-B Ammendale Road
Beltsville
,
MD
20705
United States
Mihael H. Polymeropoulos, M.D.
President and Chief Executive Officer
Vanda Pharmaceuticals Inc.
2200 Pennsylvania Ave NW, Suite 300E
Washington, DC 20037
RE: NDA 022192
FANAPT
®
(iloperidone) tablets, for oral use
MA 539
NDA 205677
HETLIOZ
®
(tasimelteon) capsules, for oral use
MA 137
Dear Dr. Polymeropoulos:
This letter responds to the Vanda Pharmaceutical’s (Vanda) November 5, 2018,
correspondence submitted to the Office of Prescription Drug Promotion (OPDP) in response
to OPDP’s October 22, 2018, Warning Letter concerning a webpage titled, “Products” for
FANAPT
®
(iloperidone) tablets, for oral use (Fanapt), and HETLIOZ
®
(tasimelteon) capsules,
for oral use (Hetlioz). Reference is also made to the November 15, 2018, teleconference
between OPDP and Vanda.
OPDP’s Warning Letter requested that Vanda immediately cease misbranding Fanapt and
Hetlioz and/or cease introducing the misbranded drugs into interstate commerce as
discussed in the Warning Letter, submit a written response on or before November 5, 2018,
stating whether you intended to comply with this request, list all promotional materials (with
the 2253 submission date) for Fanapt and Hetlioz that contain representations such as those
described in the Warning Letter, and explain Vanda’s plan for discontinuing use of such
materials, or, in the alternative, for ceasing distribution of Fanapt and Hetlioz. We also
requested that Vanda present a comprehensive plan of action to disseminate truthful, non-misleading,
and complete corrective messages about the issues discussed in the Warning
Letter to the audience(s) that received the violative promotional materials.
OPDP acknowledges that Vanda has:
•
Ceased use of the Products webpage cited as the basis for the Warning Letter and
replaced it with a revised Products webpage.
•
Issued a press release on November 1, 2018, regarding the Warning Letter.
•
Represented to OPDP that it has reviewed current promotional materials for both
products and indicated to OPDP that all such materials contain appropriate risk
information to conform with Federal regulatory requirements.
•
Represented to OPDP that it has reviewed its processes for promotional material
review and confirmed procedures to ensure that all promotional materials conform with
Federal regulatory requirements.
In light of the actions that Vanda has taken, OPDP considers this matter closed. We remind
you of your continuing obligation to ensure that all of your promotional materials comply with
each applicable requirement of the FD&C Act and FDA implementing regulations.
If you have any questions or comments, please direct your response to the undersigned at
the
Food and Drug Administration, Center for Drug Evaluation and Research, Office of
Pr
escription Drug Promotion, 5901-B Ammendale Road, Beltsville, Maryland 20705-
1266
.
A courtesy copy can be sent by facsimile to
(301) 847-8444
. To ensure timely delivery
of your submissions, please use the full address above and include a prominent directional
notation (e.g. a sticker) to indicate that the submission is intended for OPDP. Please refer to
MA 539 and MA 137 in addition to the NDA numbers in all future correspondence relating to
this particular matter. OPDP reminds you that only written communications are considered
official.
Sincerely,
{See appended electronic signature page}
Dhara Shah, PharmD, RAC
Regulatory Review Officer
Division of Advertising & Promotion Review 1
Office of Prescription Drug Promotion
--------------------------------------------------------------------------------------------
This is a representation of an electronic record that was signed
electronically. Following this are manifestations of any and all
electronic signatures for this electronic record.
--------------------------------------------------------------------------------------------
/s/
------------------------------------------------------------
DHARA SHAH
11/21/2018
Content current as of:
05/02/2019
Regulated Product(s)
Drugs