FDA halts marketing of unapproved colchicine

The FDA has informed companies that manufacture, distribute, and/or market unapproved single-ingredient oral colchicine that they are expected to stop manufacturing single-ingredient oral colchicine within 45 days and must stop shipping this unapproved product in interstate commerce within 90 days. A small amount of unapproved colchicine is expected to be available after these dates until supplies are exhausted.

Many older single-ingredient oral colchicine products have not received the mandatory modern-day FDA-approval required of all prescription drugs. Colcrys (from URL Pharma), approved in 2009, is the only FDA-approved single-ingredient oral colchicine product available on the U.S. market. URL Pharma has established a Patient Assistance Program (PAP) and a Co-Pay Assistance Program (CAP) to ensure that all patients will be able to continue affordable access to colchicine. URL Pharma also has informed the FDA that it will maintain the programs at a minimum until there is FDA-approved generic competition for Colcrys. The PAP covers three groups of people: those with insurance; those without insurance; and Medicare beneficiaries enrolled in Part D who do not want the cost of Colcrys to contribute toward their true out-of-pocket expenditures under Part D. Specific information on these programs can be found at www.colcrys.com or by calling (888) 811-8423.

Colchicine is indicated for the prophylaxis and treatment of acute gout flares, as well as for the treatment of Familial Mediterranean Fever (FMF).

For more information visit www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm227796.htm.