FDA Takes On Unapproved Single-Ingredient Colchicine

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The FDA has ordered a halt to the marketing of unapproved single-ingredient oral colchicine, a medication commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of familial Mediterranean fever.

Many single ingredient oral colchicine products have been used by the medical community for decades. These and a variety of other medications have not received the mandatory modern-day FDA-approval required of all prescription drugs. Colcrys is the only FDA-approved single-ingredient oral colchicine product available in the United States.

“The need for drugs to go through the FDA approval process is clearly demonstrated by our review of oral colchicine tablets," said Janet Woodcock, MD, Director of FDA,s Center for Drug Evaluation and Research. “Without our safety review and proper drug labeling, the old standard of care would likely have continued, to the detriment of patients.”

Unapproved versions of colchicine are not generic drugs, the agency noted. Generic drugs are approved by the FDA to assure that the approved generic drug products meet the same standards as the innovator drug. All single-ingredient oral colchicine products, other than Colcrys, that are currently being marketed are unapproved drugs and have never been evaluated by the agency.

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