{"abstract":"The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect the original approval of an abbreviated new animal drug application (ANADA) filed by Synerx Pharma, LLC. The ANADA provides for the veterinary prescription use of fomepizole injectable solution as an antidote for ethylene glycol (antifreeze) poisoning in dogs.","action":"Final rule.","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/2009/09/17/E9-22384.html","cfr_references":[{"chapter":null,"citation_url":null,"part":510,"title":21},{"chapter":null,"citation_url":null,"part":522,"title":21}],"citation":"74 FR 47725","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This rule is effective September 17, 2009.","disposition_notes":null,"docket_ids":["Docket No. FDA-2009-N-0665"],"dockets":[],"document_number":"E9-22384","effective_on":"2009-09-17","end_page":47726,"executive_order_notes":null,"executive_order_number":null,"explanation":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2009/09/17/E9-22384.xml","html_url":"https://www.federalregister.gov/documents/2009/09/17/E9-22384/new-animal-drugs-fomepizole","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/E9-22384?publication_date=2009-09-17","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2009-09-17/E9-22384/mods.xml","not_received_for_publication":null,"page_length":2,"page_views":{"count":59,"last_updated":"2026-04-04 10:15:04 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2009-09-17/pdf/E9-22384.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2009-09-17","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2009/09/17/E9-22384.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2009-09-17T18:11:10Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":47725,"subtype":null,"title":"New Animal Drugs; Fomepizole","toc_doc":"Fomepizole","toc_subject":"New Animal Drugs:","topics":[],"type":"Rule","volume":74}