{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2018/06/21/2018-13293.html","cfr_references":[],"citation":"83 FR 28856","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of July 23, 2018.","disposition_notes":null,"docket_ids":["Docket No. FDA-2018-N-2194"],"dockets":[],"document_number":"2018-13293","effective_on":null,"end_page":28857,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2018/06/21/2018-13293.xml","html_url":"https://www.federalregister.gov/documents/2018/06/21/2018-13293/novartis-pharmaceuticals-corporation-et-al-withdrawal-of-approval-of-five-new-drug-applications","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2018-13293?publication_date=2018-06-21","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2018-06-21/2018-13293/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":543,"last_updated":"2026-04-04 18:15:03 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2018-06-21/pdf/2018-13293.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2018-13293.pdf?1529498717","publication_date":"2018-06-21","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2018/06/21/2018-13293.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"supporting_documents":[],"comments_url":"https://www.regulations.gov/docketBrowser?rpp=50&so=DESC&sb=postedDate&po=0&dct=PS&D=FDA-2018-N-2194","supporting_documents_count":0,"docket_id":"FDA-2018-N-2194","regulation_id_number":null,"title":"Novartis Pharmaceuticals Corporation et al.; Withdrawal of Approval of Five New Drug Applications","checked_regulationsdotgov_at":"2018-07-11T10:00:26Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":28856,"subtype":null,"title":"Novartis Pharmaceuticals Corporation, et al.; Withdrawal of Approval of Five New Drug Applications","toc_doc":"Novartis Pharmaceuticals Corp., et al.; Withdrawal","toc_subject":"New Drug Applications:","topics":[],"type":"Notice","volume":83}