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FDA Orders Halt to Marketing of Unapproved Single-Ingredient Oral Colchicine
Date:9/30/2010

ype of action announced today."

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. The FDA is committed to working with companies to ensure that marketed drugs are safe and effective, and meet appropriate standards for manufacturing and labeling.

For more information:

Oral Colchicine Federal Register Notice

http://www.ofr.gov/inspection.aspx#reg_F

FDA's Unapproved Drugs Web site http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/EnforcementActivitiesbyFDA/SelectedEnforcementActionsonUnapprovedDrugs/default.htm

Media Inquiries: Elaine Gansz Bobo, 301.796.7567, elaine.bobo@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


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SOURCE U.S. Food and Drug Administration
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