Oxytrol, Flomax Switches Show Gap Between U.S., U.K. Pathways
This article was originally published in The Tan Sheet
EU centralized switch has proven difficult, with only two drugs making the transition from Rx to OTC in the European Medicines Agency process, and EU member state switches also remain complex. Boehringer’s Flomax U.K. switch and Merck’s Oxytrol for Women in the U.S. underscore differences in the regulatory paths.