{"abstract":"The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL) for IMBRUVICA (ibrutinib) Capsules and Tablets approved, respectively, under new drug applications (NDAs) 205552 and 210563. These NDAs are held by Pharmacyclics LLC, 1000 Gateway Blvd., South San Francisco, CA 94080 (Pharmacyclics). Pharmacyclics voluntarily requested that the Agency withdraw approval of these indications and waived its opportunity for a hearing.","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/2023/12/18/2023-27662.html","cfr_references":[],"citation":"88 FR 87435","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of December 18, 2023.","disposition_notes":null,"docket_ids":["Docket No. FDA-2023-N-5344"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2023-12-18","updated_at":"2023-12-18T09:56:02.585-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2023-N-5344-0001","allow_late_comments":null,"id":"FDA-2023-N-5344-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2023-N-5344","title":"Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets"}],"document_number":"2023-27662","effective_on":null,"end_page":87435,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2023/12/18/2023-27662.xml","html_url":"https://www.federalregister.gov/documents/2023/12/18/2023-27662/pharmacyclics-llc-withdrawal-of-approval-of-indications-for-mantle-cell-lymphoma-and-marginal-zone","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2023-27662?publication_date=2023-12-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2023-12-18/2023-27662/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":5045,"last_updated":"2026-04-03 14:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2023-12-18/pdf/2023-27662.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2023-27662.pdf?1702647918","publication_date":"2023-12-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2023/12/18/2023-27662.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-2023-N-5344","supporting_documents_count":0,"docket_id":"FDA-2023-N-5344","document_id":"FDA-2023-N-5344-0001","regulation_id_number":null,"title":"Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets","checked_regulationsdotgov_at":"2023-12-19T14:00:17Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":87435,"subtype":null,"title":"Pharmacyclics LLC.; Withdrawal of Approval of Indications for Mantle Cell Lymphoma and Marginal Zone Lymphoma for IMBRUVICA (ibrutinib) Capsules and Tablets","toc_doc":"Pharmacyclics LLC; Mantle Cell Lymphoma and Marginal Zone Lymphoma for Imbruvica (ibrutinib) Capsules and Tablets","toc_subject":"Withdrawal of Approval of Indication:\n","topics":[],"type":"Notice","volume":88}