"Until recently, there was 1 manufacturer of unapproved injectable colchicine, and that firm has ceased manufacturing the product," Deborah Autor, director of the FDA's Office of Compliance, Center for Drug Evaluation and Research (CDER), says in a statement. "This serves as the agency's warning that firms wishing to make injectable colchicine in the future must not manufacture the product until they apply for and are granted approval by the FDA to do so."
"Today's action supports our ongoing efforts to end the marketing of unapproved drugs with serious health risks," says Janet Woodcock, MD, the FDA's deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the CDER in an FDA news release. "Such products put consumers' health and sometimes their very lives at grave risk. It is a priority that these products be removed from the market."