{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of a new drug application (NDA) for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base, held by GlaxoSmithKline, LLC, 2020 Walnut Street, Philadelphia, PA 19104 (GSK). GSK notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2026/04/10/2026-06911.html","cfr_references":[],"citation":"91 FR 18472","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of April 10, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-0707"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-04-10","updated_at":"2026-04-10T10:00:39.918-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-0707-0001","allow_late_comments":false,"id":"FDA-2026-N-0707-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-0707","title":"GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base"}],"document_number":"2026-06911","effective_on":null,"end_page":18472,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/04/10/2026-06911.xml","html_url":"https://www.federalregister.gov/documents/2026/04/10/2026-06911/glaxosmithkline-withdrawal-of-approval-of-a-new-drug-application-for-wellcovorin-leucovorin-calcium","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-06911?publication_date=2026-04-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-04-10/2026-06911/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":646,"last_updated":"2026-06-15 20:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-04-10/pdf/2026-06911.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-06911.pdf?1775738708","publication_date":"2026-04-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/04/10/2026-06911.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-2026-N-0707","supporting_documents_count":0,"docket_id":"FDA-2026-N-0707","document_id":"FDA-2026-N-0707-0001","regulation_id_number":null,"title":"GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (leucovorin calcium) tablets, EQ 5 mg base and EQ 25 mg base","checked_regulationsdotgov_at":"2026-04-11T16:55:06Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":18472,"subtype":null,"title":"GlaxoSmithKline; Withdrawal of Approval of a New Drug Application for Wellcovorin (Leucovorin Calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base","toc_doc":"GlaxoSmithKline; Wellcovorin (leucovorin calcium) Tablets, EQ 5 mg Base and EQ 25 mg Base","toc_subject":"Withdrawal of Approval of Drug Application","topics":[],"type":"Notice","volume":91}