{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that OZEMPIC (semaglutide) solution, 2 milligrams (mg)/1.5 milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.","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/2026/04/30/2026-08435.html","cfr_references":[],"citation":"91 FR 23276","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-P-3849"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-04-30T11:04:20.447-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-P-3849-0004","allow_late_comments":false,"id":"FDA-2025-P-3849-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-P-3849","title":"Requests that the FDA determine whether OZEMPIC (semaglutide) Injection, 2 mg/1.5 mL (1.34 mg/mL) was withdrawn for safety or effectiveness reasons."}],"document_number":"2026-08435","effective_on":null,"end_page":23276,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/30/2026-08435.xml","html_url":"https://www.federalregister.gov/documents/2026/04/30/2026-08435/determination-that-ozempic-semaglutide-solution-2-milligrams-per-15-milliliters-was-not-withdrawn","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-08435?publication_date=2026-04-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-30/2026-08435/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":207,"last_updated":"2026-06-25 08:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-30/pdf/2026-08435.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08435.pdf?1777466717","publication_date":"2026-04-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/30/2026-08435.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"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-P-3849","supporting_documents_count":0,"docket_id":"FDA-2025-P-3849","document_id":"FDA-2025-P-3849-0004","regulation_id_number":null,"title":"Requests that the FDA determine whether OZEMPIC (semaglutide) Injection, 2 mg/1.5 mL (1.34 mg/mL) was withdrawn for safety or effectiveness reasons.","checked_regulationsdotgov_at":"2026-05-01T13:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23276,"subtype":null,"title":"Determination That OZEMPIC (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Ozempic (Semaglutide) Solution, 2 Milligrams Per 1.5 Milliliters","toc_subject":"Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}