{"abstract":"The Director of the Center for Drug Evaluation and Research (Center Director) at the Food and Drug Administration (FDA or Agency) is proposing to refuse to approve a supplemental new drug application (sNDA) submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), in its present form. This notice summarizes the grounds for the Center Director's proposal and offers Vanda an opportunity to request a hearing on the matter.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services Department","id":221,"url":"https://www.federalregister.gov/agencies/health-and-human-services-department","json_url":"https://www.federalregister.gov/api/v1/agencies/221","parent_id":null,"slug":"health-and-human-services-department"},{"raw_name":"Food and Drug Administration","name":"Food and Drug Administration","id":199,"url":"https://www.federalregister.gov/agencies/food-and-drug-administration","json_url":"https://www.federalregister.gov/api/v1/agencies/199","parent_id":221,"slug":"food-and-drug-administration"}],"body_html_url":"https://www.federalregister.gov/documents/full_text/html/2024/06/07/2024-12564.html","cfr_references":[],"citation":"89 FR 48647","comment_url":null,"comments_close_on":"2024-08-06","correction_of":null,"corrections":[],"dates":"Either electronic or written requests for a hearing must be submitted by July 8, 2024; submit data, information, and analyses in support of the hearing and any other comments by August 6, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2022-N-2390"],"dockets":[{"supporting_documents":[{"title":"Exhibit 92","document_id":"FDA-2022-N-2390-0228"},{"title":"Exhibit 84","document_id":"FDA-2022-N-2390-0220"},{"title":"Exhibit 75","document_id":"FDA-2022-N-2390-0211"},{"title":"Exhibit 59","document_id":"FDA-2022-N-2390-0195"},{"title":"Exhibit 35","document_id":"FDA-2022-N-2390-0171"},{"title":"Exhibit 30","document_id":"FDA-2022-N-2390-0166"},{"title":"Exhibit 26","document_id":"FDA-2022-N-2390-0162"},{"title":"Exhibit 15","document_id":"FDA-2022-N-2390-0151"},{"title":"Exhibit 9","document_id":"FDA-2022-N-2390-0145"},{"title":"Exhibit 6","document_id":"FDA-2022-N-2390-0142"}],"agency_name":"FDA","documents":[{"comment_count":1,"comment_start_date":"2024-06-07","updated_at":"2026-09-16T01:56:48.344-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-2390-0035","allow_late_comments":false,"id":"FDA-2022-N-2390-0035","comment_end_date":"2024-08-07","regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":704,"id":"FDA-2022-N-2390","title":"Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing"}],"document_number":"2024-12564","effective_on":null,"end_page":48649,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/06/07/2024-12564.xml","html_url":"https://www.federalregister.gov/documents/2024/06/07/2024-12564/proposal-to-refuse-to-approve-a-new-drug-application-supplement-for-hetlioz-tasimelteon-opportunity","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-12564?publication_date=2024-06-07","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-06-07/2024-12564/mods.xml","not_received_for_publication":null,"page_length":3,"page_views":{"count":378,"last_updated":"2026-10-24 16:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-06-07/pdf/2024-12564.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-12564.pdf?1717677946","publication_date":"2024-06-07","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/06/07/2024-12564.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Exhibit 92","document_id":"FDA-2022-N-2390-0228"},{"title":"Exhibit 84","document_id":"FDA-2022-N-2390-0220"},{"title":"Exhibit 75","document_id":"FDA-2022-N-2390-0211"},{"title":"Exhibit 59","document_id":"FDA-2022-N-2390-0195"},{"title":"Exhibit 35","document_id":"FDA-2022-N-2390-0171"},{"title":"Exhibit 30","document_id":"FDA-2022-N-2390-0166"},{"title":"Exhibit 26","document_id":"FDA-2022-N-2390-0162"},{"title":"Exhibit 15","document_id":"FDA-2022-N-2390-0151"},{"title":"Exhibit 9","document_id":"FDA-2022-N-2390-0145"},{"title":"Exhibit 6","document_id":"FDA-2022-N-2390-0142"}],"comments_count":1,"agency_id":"FDA","comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2022-N-2390","supporting_documents_count":698,"docket_id":"FDA-2022-N-2390","document_id":"FDA-2022-N-2390-0035","regulation_id_number":null,"title":"Proposal To Refuse To Approve a New Drug Application Supplement for Hetlioz (Tasimelteon); Opportunity for a Hearing","checked_regulationsdotgov_at":"2026-09-17T08:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":48647,"subtype":null,"title":"Proposal To Refuse To Approve a New Drug Application Supplement for HETLIOZ (Tasimelteon); Opportunity for a Hearing","toc_doc":"Hetlioz (Tasimelteon)","toc_subject":"Proposal to Refuse To Approve a New Drug Application Supplement:\n","topics":[],"type":"Notice","volume":89}