What action is FDA taking regarding single-ingredient oral colchicine drug products?
The U.S. Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved single-ingredient oral colchicine products. Under the notice published in the Federal Register, firms marketing any unapproved single-ingredient oral colchicine products must stop manufacturing these products within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. After these dates, all single-ingredient oral colchicine products must have FDA approval to be manufactured or shipped interstate.
