{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2 mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and regulatory requirements are met.","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/2024/11/19/2024-26915.html","cfr_references":[],"citation":"89 FR 91410","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2024-P-3482"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2024-11-19","updated_at":"2024-11-19T10:56:50.844-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-P-3482-0003","allow_late_comments":false,"id":"FDA-2024-P-3482-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-P-3482","title":"Requests that FDA determine whether JESDUVROQ ( daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, approved under New Drug Application (\"NDA\") number 216951, held by GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND, has been voluntarily withdrawn for reasons of safety or effectiveness"}],"document_number":"2024-26915","effective_on":null,"end_page":91410,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/11/19/2024-26915.xml","html_url":"https://www.federalregister.gov/documents/2024/11/19/2024-26915/determination-that-jesduvroq-daprodustat-tablets-1-milligram-2-milligrams-4-milligrams-6-milligrams","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-26915?publication_date=2024-11-19","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-11-19/2024-26915/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":1114,"last_updated":"2026-10-23 18:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-11-19/pdf/2024-26915.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-26915.pdf?1731937535","publication_date":"2024-11-19","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/11/19/2024-26915.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-2024-P-3482","supporting_documents_count":0,"docket_id":"FDA-2024-P-3482","document_id":"FDA-2024-P-3482-0003","regulation_id_number":null,"title":"Requests that FDA determine whether JESDUVROQ ( daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, approved under New Drug Application (\"NDA\") number 216951, held by GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND, has been voluntarily withdrawn for reasons of safety or effectiveness","checked_regulationsdotgov_at":"2024-11-20T15:00:16Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":91410,"subtype":null,"title":"Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Jesduvroq (Daprodustat) Tablets, 1 Milligram, 2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams","toc_subject":"Drug Products not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":89}