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Why Did Germany Reject Sildenafil OTC Switch?

Executive Summary

Sildenafil was rejected at Germany’s independent switch committee’s most recent meeting. HBW Insight examines some of the arguments for and against the switch put forward by the regulator, members of the committee and the applicant, as recorded in the recently published minutes.

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Germany's Ministry of Health surprised all those present at a recent BAH meeting by announcing it would like to see erectile dysfunction drugs like sildenafil and tadalafil available OTC. Such a move, however, would put the government at odds with drug regulator BfArM's Expert Committee for Prescription, which recently rejected an application for the Rx-to-OTC switch of sildenafil. 

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