{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness.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/2025/05/30/2025-09772.html","cfr_references":[],"citation":"90 FR 23056","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2025-P-0101"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2025-05-30","updated_at":"2025-05-30T10:57:23.265-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2025-P-0101-0004","allow_late_comments":false,"id":"FDA-2025-P-0101-0004","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2025-P-0101","title":"Requests that the FDA determine whether the Reference Listed Drug (RLD) COREG CR (carvedilol phosphate) extended-release capsules, 10 mg, 20 mg, 40 mg and 80 mg under New Drug Application (NDA) 022012 held by WAYLIS THERAPEUTICS LLC was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons."}],"document_number":"2025-09772","effective_on":null,"end_page":23056,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2025/05/30/2025-09772.xml","html_url":"https://www.federalregister.gov/documents/2025/05/30/2025-09772/determination-that-coreg-cr-carvedilol-phosphate-extended-release-capsules-10-milligrams-20","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2025-09772?publication_date=2025-05-30","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2025-05-30/2025-09772/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":670,"last_updated":"2026-06-24 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2025-05-30/pdf/2025-09772.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2025-09772.pdf?1748522711","publication_date":"2025-05-30","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2025/05/30/2025-09772.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-0101","supporting_documents_count":0,"docket_id":"FDA-2025-P-0101","document_id":"FDA-2025-P-0101-0004","regulation_id_number":null,"title":"Requests that the FDA determine whether the Reference Listed Drug (RLD) COREG CR (carvedilol phosphate) extended-release capsules, 10 mg, 20 mg, 40 mg and 80 mg under New Drug Application (NDA) 022012 held by WAYLIS THERAPEUTICS LLC was voluntarily withdrawn from commercial distribution or withdrawn from sale for safety or efficacy reasons.","checked_regulationsdotgov_at":"2025-05-31T17:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":23056,"subtype":null,"title":"Determination That COREG CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 20 Milligrams, 40 Milligrams, and 80 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Coreg CR (Carvedilol Phosphate) Extended-Release Capsules, 10 Milligrams, 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":90}