{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug application (NDA) for ALIQOPA (copanlisib) for injection, 60 milligrams (mg)/vial, held by Bayer HealthCare Pharmaceuticals Inc., 100 Bayer Blvd., Whippany, NJ 07981- 0915. Bayer HealthCare Pharmaceuticals Inc. (Bayer) has voluntarily requested that FDA withdraw approval of this application and has 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/2024/03/18/2024-05619.html","cfr_references":[],"citation":"89 FR 19327","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of March 18, 2024.","disposition_notes":null,"docket_ids":["Docket No. FDA-2024-N-1180"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":null,"updated_at":"2024-03-18T09:56:02.195-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2024-N-1180-0001","allow_late_comments":null,"id":"FDA-2024-N-1180-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2024-N-1180","title":"Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial"}],"document_number":"2024-05619","effective_on":null,"end_page":19327,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2024/03/18/2024-05619.xml","html_url":"https://www.federalregister.gov/documents/2024/03/18/2024-05619/bayer-healthcare-pharmaceuticals-inc-withdrawal-of-approval-of-new-drug-application-for-aliqopa","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2024-05619?publication_date=2024-03-18","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2024-03-18/2024-05619/mods.xml","not_received_for_publication":null,"page_length":1,"page_views":{"count":3165,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2024-03-18/pdf/2024-05619.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2024-05619.pdf?1710506717","publication_date":"2024-03-18","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2024/03/18/2024-05619.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-N-1180","supporting_documents_count":0,"docket_id":"FDA-2024-N-1180","document_id":"FDA-2024-N-1180-0001","regulation_id_number":null,"title":"Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial","checked_regulationsdotgov_at":"2024-03-21T12:00:12Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":19327,"subtype":null,"title":"Bayer HealthCare Pharmaceuticals Inc.; Withdrawal of Approval of New Drug Application for ALIQOPA (Copanlisib) for Injection, 60 Milligrams per Vial","toc_doc":"Bayer HealthCare Pharmaceuticals Inc.; Aliqopa (Copanlisib) for Injection, 60 Milligrams per Vial","toc_subject":"Withdrawal of Approval of Drug Application:\n","topics":[],"type":"Notice","volume":89}