{"abstract":"The Food and Drug Administration (FDA or agency) is announcing its intention to take enforcement action against unapproved single- ingredient oral colchicine products and persons\\1\\ who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved single-ingredient oral colchicine products have been associated with serious adverse events, including fatalities. Single-ingredient oral colchicine products are new drugs that require approved applications because they are not generally recognized as safe and effective. Currently one firm has obtained approved applications to market single-ingredient oral colchicine for the treatment of acute gout flares, prophylaxis of gout flares, and prophylaxis of attacks of Familial Mediterranean Fever (FMF). All other manufacturers who wish to market single-ingredient oral colchicine products for these or other indications must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA). ---------------------------------------------------------------------------","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/2010/10/01/2010-24684.html","cfr_references":[],"citation":"75 FR 60768","comment_url":null,"comments_close_on":null,"correction_of":null,"corrections":[],"dates":"This notice is effective October 1, 2010. For information about","disposition_notes":null,"docket_ids":["Docket No. FDA-2010-N-0257"],"dockets":[],"document_number":"2010-24684","effective_on":"2010-10-01","end_page":60771,"executive_order_notes":null,"executive_order_number":null,"full_text_xml_url":"https://www.federalregister.gov/documents/full_text/xml/2010/10/01/2010-24684.xml","html_url":"https://www.federalregister.gov/documents/2010/10/01/2010-24684/single-ingredient-oral-colchicine-products-enforcement-action-dates","images":{},"images_metadata":{},"json_url":"https://www.federalregister.gov/api/v1/documents/2010-24684?publication_date=2010-10-01","mods_url":"https://www.govinfo.gov/metadata/granule/FR-2010-10-01/2010-24684/mods.xml","not_received_for_publication":null,"page_length":4,"page_views":{"count":1665,"last_updated":"2026-08-26 22:15:05 -0400"},"pdf_url":"https://www.govinfo.gov/content/pkg/FR-2010-10-01/pdf/2010-24684.pdf","presidential_document_number":null,"proclamation_number":null,"public_inspection_pdf_url":null,"publication_date":"2010-10-01","raw_text_url":"https://www.federalregister.gov/documents/full_text/text/2010/10/01/2010-24684.txt","regulation_id_number_info":{},"regulation_id_numbers":[],"regulations_dot_gov_info":{"checked_regulationsdotgov_at":"2010-10-21T12:19:41Z"},"regulations_dot_gov_url":null,"significant":null,"signing_date":null,"start_page":60768,"subtype":null,"title":"Single-Ingredient Oral Colchicine Products; Enforcement Action Dates","toc_doc":"Single-Ingredient Oral Colchicine Products; Enforcement Action Dates","toc_subject":null,"topics":[],"type":"Notice","volume":75}