Vanda Pharmaceuticals

CLOSEOUT LETTER Vanda Pharmaceuticals MARCS-CMS 576442 — November 21, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters 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