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Unapproved colchicine drugs face FDA enforcement

Executive Summary

Companies marketing unapproved injectable colchicine drugs used to treat gout have 30 days to stop manufacturing and 180 days to stop shipping the highly toxic intravenous drug, which has caused 23 reported deaths, according to a Feb. 6 FDA statement. Refusal could result in regulatory action, including seizure, injunction or other legal action. The enforcement measure marks the seventh action taken by the agency against companies marketing and selling unapproved drugs since issuing its Compliance Policy Guide (1"The Pink Sheet" June 12, 2006, p. 10). After the 180-day period, all colchicine drugs must have FDA approval to be manufactured or shipped interstate...

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