{"abstract":"The Food and Drug Administration (FDA or the Agency) is announcing the availability of the decision to deny a request for a hearing regarding the proposal of the Center for Drug Evaluation and Research (CDER) to refuse to approve the supplemental new drug application (sNDA) 205677-004, submitted by Vanda Pharmaceuticals, Inc. (Vanda), for HETLIOZ (tasimelteon) capsules, 20 milligrams (mg), for the treatment of jet lag disorder. The decision, which also refuses approval of sNDA 205677-004, is available in the docket identified by the number in the heading of this document.","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/2024/03/06/2024-04735.html","cfr_references":[],"citation":"89 FR 16001","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"The decision was published in the docket on March 1, 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":0,"comment_start_date":"2024-03-06","updated_at":"2024-09-03T16:45:46.423-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2022-N-2390-0034","allow_late_comments":false,"id":"FDA-2022-N-2390-0034","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":530,"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":"2024-04735","effective_on":null,"end_page":16001,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/06/2024-04735.xml","html_url":"https://www.federalregister.gov/documents/2024/03/06/2024-04735/notice-of-the-denial-of-a-hearing-request-regarding-a-proposal-to-refuse-to-approve-a-supplemental","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-04735?publication_date=2024-03-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-06/2024-04735/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":199,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-06/pdf/2024-04735.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-04735.pdf?1709646332","publication_date":"2024-03-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/06/2024-04735.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":0,"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":530,"docket_id":"FDA-2022-N-2390","document_id":"FDA-2022-N-2390-0034","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":"2024-03-07T15:00:09Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":16001,"subtype":null,"title":"Notice of the Denial of a Hearing Request Regarding a Proposal To Refuse To Approve a Supplemental New Drug Application for HETLIOZ (Tasimelteon)","toc_doc":"Proposal to Refuse to Approve a Supplemental New Drug Application for Hetlioz (Tasimelteon)","toc_subject":"Denial of a Hearing Request:\n","topics":[],"type":"Notice","volume":89}