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In July 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 [66]). This resulted in a 3-year regulatory market exclusivity in the acute and chronic gout indications and a 7-year exclusivity on the FMF indication.
In 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) [4] and gave URL Pharma a three-year marketing exclusivity agreement [5] in exchange for URL Pharma doing 17 new studies and investing $100 million into ...
Although the exact mechanism of colchicine is not fully understood, its anti-inflammatory effect for pericarditis appears to be related to its ability to inhibit microtubule self-assembly, resulting in decreased leucocyte motility and phagocytosis. Other non-FDA-approved uses include actinic keratosis, amyloidosis, Peyronie's disease, and ...
While colchicine is not used to treat cancer in humans, it is commonly used to treat acute attacks of gout. [26] Colchicine is an anti-inflammatory drug that has been in continuous use for more than 3000 years. Colchicine is an oral drug, known to be used for treating acute gout and preventing acute attacks of familial Mediterranean fever (FMF).
The bulb-like corms of C. autumnale contain colchicine, a useful drug with a narrow therapeutic index. Colchicine is approved in many countries for the treatment of gout and familial Mediterranean fever. Colchicine is also used in plant breeding to produce polyploid strains. [citation needed]
6 Colchicine as an FDA approved drug. 4 comments. 7 Peyronie. 1 comment. 8 Cash-strapped FDA. 1 comment. 9 >50-fold viewing spike on 14 January 2011. 1 comment.
US FDA-approved: Azithromycin – unique; does not extensively inhibit CYP3A4 ... Symptoms of colchicine toxicity include gastrointestinal upset, fever, myalgia ...
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...