{"abstract":"The Food and Drug Administration (FDA or Agency) is withdrawing approval of 11 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.","action":"Notice.","agencies":[{"raw_name":"DEPARTMENT OF HEALTH AND HUMAN SERVICES","name":"Health and Human Services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/2026/02/20/2026-03411.html","cfr_references":[],"citation":"91 FR 8242","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"Approval is withdrawn as of March 23, 2026.","disposition_notes":null,"docket_ids":["Docket No. FDA-2026-N-1224"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":0,"comment_start_date":"2026-02-20","updated_at":"2026-02-20T10:57:56.684-05:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-N-1224-0001","allow_late_comments":false,"id":"FDA-2026-N-1224-0001","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-N-1224","title":"Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications"}],"document_number":"2026-03411","effective_on":null,"end_page":8243,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/02/20/2026-03411.xml","html_url":"https://www.federalregister.gov/documents/2026/02/20/2026-03411/masuu-global-solutions-llc-us-agent-for-extrovis-ag-et-al-withdrawal-of-approval-of-11-abbreviated","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-03411?publication_date=2026-02-20","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-02-20/2026-03411/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":177,"last_updated":"2026-04-04 20:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-02-20/pdf/2026-03411.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-03411.pdf?1771508719","publication_date":"2026-02-20","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/02/20/2026-03411.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-1224","supporting_documents_count":0,"docket_id":"FDA-2026-N-1224","document_id":"FDA-2026-N-1224-0001","regulation_id_number":null,"title":"Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications","checked_regulationsdotgov_at":"2026-02-21T19:55:03Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":8242,"subtype":null,"title":"Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.; Withdrawal of Approval of 11 Abbreviated New Drug Applications","toc_doc":"Masuu Global Solutions LLC, U.S. Agent for Extrovis AG, et al.","toc_subject":"Withdrawal of Approval of Drug Application","topics":[],"type":"Notice","volume":91}