{"abstract":"The Food and Drug Administration (FDA, the Agency, or we) is announcing that we have reviewed information in published literature that seems promising regarding the potential use of testosterone replacement therapy (TRT) in the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism. We encourage holders of approved TRT new drug applications (NDAs) that are interested in seeking approval for this new indication to contact FDA for further information regarding submission of a supplemental NDA, including data needed to support an approval.","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/2026/04/20/2026-07615.html","cfr_references":[],"citation":"91 FR 21002","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Holders of currently approved TRT NDAs interested in seeking approval for the treatment of low libido in men with decreased libido associated with idiopathic hypogonadism are encouraged to contact FDA (see FOR FURTHER INFORMATION CONTACT) by April 30, 2026, for further information regarding submission of a supplemental NDA, including data needed to support the new indication.","disposition_notes":null,"docket_ids":["Docket No. FDA-2025-N-6743"],"dockets":[{"supporting_documents":[{"title":"Effects of Testosterone Treatment in Older Men","document_id":"FDA-2025-N-6743-2004"},{"title":"Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism","document_id":"FDA-2025-N-6743-2003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-04-20","updated_at":"2026-04-20T10:56:45.506-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-N-6743-2002","allow_late_comments":false,"id":"FDA-2025-N-6743-2002","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":2,"id":"FDA-2025-N-6743","title":"Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information"}],"document_number":"2026-07615","effective_on":null,"end_page":21003,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/20/2026-07615.xml","html_url":"https://www.federalregister.gov/documents/2026/04/20/2026-07615/potential-new-indication-for-testosterone-replacement-therapy","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-07615?publication_date=2026-04-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-20/2026-07615/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":709,"last_updated":"2026-06-25 04:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-20/pdf/2026-07615.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-07615.pdf?1776352518","publication_date":"2026-04-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/20/2026-07615.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Effects of Testosterone Treatment in Older Men","document_id":"FDA-2025-N-6743-2004"},{"title":"Effect of Testosterone Replacement Therapy on Sexual Function and Hypogonadal Symptoms in Men with Hypogonadism","document_id":"FDA-2025-N-6743-2003"}],"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-2025-N-6743","supporting_documents_count":2,"docket_id":"FDA-2025-N-6743","document_id":"FDA-2025-N-6743-2002","regulation_id_number":null,"title":"Food and Drug Administration Expert Panel on Testosterone Replacement Therapy for Men; Request for Information","checked_regulationsdotgov_at":"2026-04-21T11:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":21002,"subtype":null,"title":"Potential New Indication for Testosterone Replacement Therapy","toc_doc":"Potential New Indication for Testosterone Replacement Therapy","toc_subject":null,"topics":[],"type":"Notice","volume":91}