People suffering from unbearable gout pain shoots are about to have fewer options for relief. The FDA is requiring drug manufacturers to stop sending not approved colchicine gout, within three months of treatment.
Colchicine has been a gout remedy so long, that use preceded to the FDA, and so several companies made and sold do not require approval of the Agency for hacerlo.Pero last year, a company of Philadelphia call URL Pharma gained FDA approval for its product of colchicine, Colcrys, to treat acute gout pain.
The FDA approval URL Pharma gave some exclusive rights sales. And since then the company sick doctors pain and gout have been waiting (unfortunately, except in the case of Pharma URL) FDA to order unapproved colchicine out-of-market products.
Big rub for patients and the medical is that URL Pharma has price Colcrys about 5 $ per pill, much more than the pence to Tablet PC that costs of colchicine unapproved.Some physicians have complained because colchicine is often prescribed to prevent attacks of gout, necessitating an expensive two tablets a day.
The WSJ has written about it shakes with gout.
"In a letter to members medical, American College of Rheumatology President Stanley Cohen says that the Group has encouraged manufacturers of colchicine to seek approval from the FDA for the chronic use of the company, which was not identified, has done it, droga.Una writes Cohen.""We are hopeful FDA carried an expedited review process to make possible cost relief available to our patients", writes.
URL Pharma, for its part, said in a statement to the press which is offering financial support to certain patients have problems to deliver Colcrys, including reduction of co-payments to $ 25.
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