{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that LASIX (furosemide) tablets, 20 milligrams (mg), 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness.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/2026/08/14/2026-16648.html","cfr_references":[],"citation":"91 FR 52702","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-P-4698"],"dockets":[{"supporting_documents":[{"title":"Attachment 1: November 2025 Cumulative Supplement update for LASIX TABLETS","document_id":"FDA-2026-P-4698-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-08-14","updated_at":"2026-08-14T10:57:22.473-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-P-4698-0004","allow_late_comments":false,"id":"FDA-2026-P-4698-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2026-P-4698","title":"Request that the FDA determine whether the Reference Listed Drug (RLD) LASIX TABLETS, 20 mg, 40 mg and 80 mg; New Drug Application (NDA) 016273 of VALIDUS PHARMACEUTICALS LLC has been voluntarily withdrawn from sale for safety or efficacy reasons"}],"document_number":"2026-16648","effective_on":null,"end_page":52702,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/14/2026-16648.xml","html_url":"https://www.federalregister.gov/documents/2026/08/14/2026-16648/determination-that-lasix-furosemide-tablets-20-milligrams-40-milligrams-and-80-milligrams-were-not","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16648?publication_date=2026-08-14","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-14/2026-16648/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":171,"last_updated":"2026-09-22 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-14/pdf/2026-16648.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16648.pdf?1786625119","publication_date":"2026-08-14","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/14/2026-16648.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1: November 2025 Cumulative Supplement update for LASIX TABLETS","document_id":"FDA-2026-P-4698-0003"}],"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-2026-P-4698","supporting_documents_count":1,"docket_id":"FDA-2026-P-4698","document_id":"FDA-2026-P-4698-0004","regulation_id_number":null,"title":"Request that the FDA determine whether the Reference Listed Drug (RLD) LASIX TABLETS, 20 mg, 40 mg and 80 mg; New Drug Application (NDA) 016273 of VALIDUS PHARMACEUTICALS LLC has been voluntarily withdrawn from sale for safety or efficacy reasons","checked_regulationsdotgov_at":"2026-08-15T18:55:11Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":52702,"subtype":null,"title":"Determination That LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"LASIX (Furosemide) Tablets, 20 Milligrams, 40 Milligrams, and 80 Milligrams","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}