EMA’s Frias Defends EU Centralized Switch Procedure Despite Only Delivering Four Reclassifications In 10 Years
Despite delivering only four switches in 10 years, the European Union’s centralized switch procedure was defended by the EMA's Zaide Frias at AESGP's March regulatory conference. Frias pointed to the recent success of HRA Pharma's EllaOne, to the role of pharmacists in driving switches and to the possibility of an OTC Expert Forum as ways forward for the procedure.
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Men in Germany can now purchase premature ejaculation treatment Fortacin without a prescription as a result of the EU-wide switch of the drug earlier this year.
European Commission approval of Fortacin as OTC premature ejaculation treatment makes it only the fifth drug switched EU-wide through the centralized procedure.
Premature ejaculation treatment Fortacin is set to become only the fifth drug to achieve an Rx-to-OTC switch through European Medicines Agency's centralized procedure, expanding the burgeoning OTC men's sexual health category.