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25 on july 30, 2009 the fda approved colchicine as a monotherapy for the treatment of three different indications familial mediterranean fever, acute gout flares, and for the prophylaxis of gout flares 25 , and gave url pharma a three-year marketing exclusivity agreement 26 in exchange for url pharma doing 17 new studies and investing 100 million into the product, of which 45 million went to the fda for the application fee.

Colchicine generic

Colchicine is a highly soluble alkaloid, originally extracted from plants of the genus colchicum.

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As voriconazole, cimetidine, and fluconazole are known as cyp3a4 inhibitors that do not inhibit p-gp, these studies show that cyp3a4 inhibition by itself may not lead to clinically significant increases in colchicine systemic levels in humans, and p-gp inhibition in addition to cyp3a4 inhibition may be necessary for clinically meaningful interactions of colchicine.

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34 in september 2010, the fda ordered a halt to marketing unapproved single-ingredient oral colchicine.

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