Concepedia

Publication | Open Access

Electronic Health Record Use by Sex Among Physicians in an Academic Health Care System

32

Citations

7

References

2020

Year

Abstract

high-dose colchicine in the treatment of acute gout. 4 Consistent with the recommendations of the European League Against Rheumatism, low-dose colchicine was found to be equally effective as high-dose drug in the reduction of gouty pain; the rate of gastrointestinal adverse events with lowdose colchicine was one-third that observed with high-dose colchicine. In response to these study findings, the FDA approved Colcrys, which, consequently, became the first colchicine product to ever be approved for the treatment of acute gout. Considering that the Waxman-Hatch Act (https://www. govinfo.gov/content/pkg/STATUTE-98/pdf/STATUTE-98-Pg1585.pdf) resulted in market exclusivity for a newly approved drug, URL Pharma received this benefit. In addition to a period of exclusivity, the manufacturer was able to remove all generic competitors from the market. Upon FDA approval, the manufacturer increased the price of colchicine from what had previously been only a few cents to $5 a tablet. A second colchicine brand-name product (Mitigare) was approved in 2015 at the very conclusion of the 4-year Colcrys monopoly.

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