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FDA Takes Action to Halt Manufacture and Distribution of Unapproved Single-Ingredient Oral Colchicine
On September 30, 2010, FDA ordered companies that manufacture unapproved single-ingredient oral colchicine, a medication commonly used as treatment for gout, to stop the manufacture, distribution, and/or marketing of the drug. The companies are expected to stop manufacturing the drug within 45 days of the notice and must stop shipping in interstate commerce within 90 days. Colcrys, manufactured by Mutual Pharmaceutical Pharma, is the only FDA-approved single-ingredient oral colchicine product available on the US market. The action to halt the manufacture of unapproved single-ingredient oral colchicine is part of the FDA’s ongoing initiative against marketed unapproved drugs and aims to ensure that such medications meet current FDA standards for safety, efficacy, labeling, and quality. As quoted in an FDA press release, Deborah M. Autor, director of Center for Drug Evaluation and Research’s Office of Compliance notes that “FDA remains committed to ensuring that prescription drugs have the necessary FDA approval.”
