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Boehringer Launches Switched Flomax Relief MR For BPH In U.K.

This article was originally published in The Tan Sheet

Executive Summary

Boehringer Ingelheim's U.K. launch of nonprescription Flomax Relief MR for benign prostatic hyperplasia opens a new switch category abroad, but a similar Rx-to-OTC move in the U.S would be more difficult, one expert says

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Oxytrol, Flomax Switches Show Gap Between U.S., U.K. Pathways

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.

Oxytrol, Flomax Switches Show Gap Between U.S., U.K. Pathways

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.

OTC Oxytrol Approval In U.S. Highlights European Switch Struggles

Former McNeil Consumer Pharmaceuticals exec Stephen Mann says FDA’s approval of OTC Oxytrol poses a challenge to the EU, where Rx-to-OTC switches and the self-care movement face major obstacles. More regulators are weighing drug switches for chronic conditions, consultant Susan Coleman says.

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