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SILVER SPRING, Md. The Food and Drug Administration is cracking down on companies that sell an unapproved treatment for gout, the agency said Thursday.
The FDA announced that it had taken action against companies that manufacture, distribute and market single-ingredient oral colchicine, a drug that has existed since the early 1800s. Only one single-ingredient colchicine drug, Mutual Pharmaceutical’s and URL Pharma’s Colcrys, is approved for treating gout.
The FDA said a number of single-ingredient oral colchicine drugs have been used for decades, but they have not received approval from the modern FDA.