{"abstract":"The Food and Drug Administration (FDA, Agency, or we) has determined that OZOBAX (baclofen) oral solution, 5 milligrams (mg)/5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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/2026/08/10/2026-16248.html","cfr_references":[],"citation":"91 FR 51492","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":null,"disposition_notes":null,"docket_ids":["Docket No. FDA-2026-P-6298"],"dockets":[{"supporting_documents":[],"agency_name":"FDA","documents":[{"comment_count":null,"comment_start_date":null,"updated_at":"2026-08-10T09:56:30.624-04:00","comment_url":"https://www.regulations.gov/commenton/FDA-2026-P-6298-0003","allow_late_comments":false,"id":"FDA-2026-P-6298-0003","comment_end_date":null,"regulations_dot_gov_open_for_comment":false}],"supporting_documents_count":0,"id":"FDA-2026-P-6298","title":"Requests that the FDA to determine if the Reference Listed Drug (RLD), OZOBAX (BACLOFEN) ORAL SOLUTION 5MG/5ML, NDA 208193 owned by METACEL PHARMACEUTICALS LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version"}],"document_number":"2026-16248","effective_on":null,"end_page":51493,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2026/08/10/2026-16248.xml","html_url":"https://www.federalregister.gov/documents/2026/08/10/2026-16248/determination-that-ozobax-baclofen-oral-solution-5-milligrams5-milliliters-was-not-withdrawn-from","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2026-16248?publication_date=2026-08-10","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2026-08-10/2026-16248/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":176,"last_updated":"2026-09-22 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2026-08-10/pdf/2026-16248.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":"https://public-inspection.federalregister.gov/2026-16248.pdf?1786106714","publication_date":"2026-08-10","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2026/08/10/2026-16248.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-P-6298","supporting_documents_count":0,"docket_id":"FDA-2026-P-6298","document_id":"FDA-2026-P-6298-0003","regulation_id_number":null,"title":"Requests that the FDA to determine if the Reference Listed Drug (RLD), OZOBAX (BACLOFEN) ORAL SOLUTION 5MG/5ML, NDA 208193 owned by METACEL PHARMACEUTICALS LLC was voluntarily withdrawn from sale for reasons of safety or effectiveness to facilitate the approval of generic version","checked_regulationsdotgov_at":"2026-08-11T16:55:04Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":51492,"subtype":null,"title":"Determination That OZOBAX (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness","toc_doc":"Ozobax (Baclofen) Oral Solution, 5 Milligrams/5 Milliliters","toc_subject":"Drug Products Not Withdrawn from Sale for Reasons of Safety or Effectiveness","topics":[],"type":"Notice","volume":91}