{"abstract":"The Food and Drug Administration (FDA or Agency) has determined that DEXAMETHASONE (dexamethasone) elixir, 0.5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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/2026/05/06/2026-08939.html","cfr_references":[],"citation":"91 FR 24548","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-P-1306"],"dockets":[{"supporting_documents":[{"title":"Attachment 1","document_id":"FDA-2026-P-1306-0003"}],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-05-06","updated_at":"2026-05-06T15:05:23.285-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-P-1306-0004","allow_late_comments":false,"id":"FDA-2026-P-1306-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":1,"id":"FDA-2026-P-1306","title":"Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons."}],"document_number":"2026-08939","effective_on":null,"end_page":24549,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/05/06/2026-08939.xml","html_url":"https://www.federalregister.gov/documents/2026/05/06/2026-08939/determination-that-dexamethasone-dexamethasone-elixir-05-milligrams5-milliliters-was-not-withdrawn","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-08939?publication_date=2026-05-06","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-05-06/2026-08939/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":118,"last_updated":"2026-05-25 12:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-05-06/pdf/2026-08939.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-08939.pdf?1777985131","publication_date":"2026-05-06","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/05/06/2026-08939.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[{"title":"Attachment 1","document_id":"FDA-2026-P-1306-0003"}],"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-1306","supporting_documents_count":1,"docket_id":"FDA-2026-P-1306","document_id":"FDA-2026-P-1306-0004","regulation_id_number":null,"title":"Requests that the FDA to determine whether the Reference Listed Drug (RLD) DEXAMETHASONE ELIXIR, 0.5 mg/5 mL; Abbreviated New Drug Application (ANDA) 088254 of PHARMOBEDIENT CONSULTING has been voluntarily withdrawn from sale for safety or efficacy reasons.","checked_regulationsdotgov_at":"2026-05-07T10:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":24548,"subtype":null,"title":"Determination That DEXAMETHASONE (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Dexamethasone (Dexamethasone) Elixir, 0.5 Milligrams/5 Milliliters","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}