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  5. Vanda Pharmaceuticals - 576442 - 11/21/2018
  1. Warning Letters

CLOSEOUT LETTER

Vanda Pharmaceuticals MARCS-CMS 576442 —

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 Prescription 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

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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.

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/s/

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DHARA SHAH

11/21/2018

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