FDA orders halt to marketing of unapproved single-ingredient oral colchicine

On 30^th September, the U.S. Food and Drug Administration took action against companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine.
Colchicine is commonly used for the daily prevention of gout, to treat acute gout flare-ups, and for the treatment of Familial Mediterranean Fever (FMF).
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.,
This action is part of the FDA's broader initiative against marketed unapproved drugs, announced in a June 2006 Compliance Policy Guide describing the agency’s risk-based enforcement approach for marketed unapproved drug products.
Unapproved versions of colchicine are not generic drugs. 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.
The FDA previously took action against unapproved colchicine for injection products on Feb. 6, 2008. This ongoing initiative is designed to bring all unapproved medications, including single-ingredient oral colchicine, up to modern-day safety, efficacy, labeling, and quality standards by ensuring that they comply with FDA approval requirements.
Colcrys is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227796.htm

www.colcrys.com