EMA Approves EU-Wide Rx-to-OTC Switch Of Fortacin
Premature ejaculation treatment Fortacin is set to become only the fifth drug to achieve an Rx-to-OTC switch through EMA's centralized procedure, expanding the burgeoning OTC men's sexual health category.
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European Commission approval of Fortacin as OTC premature ejaculation treatment makes it only the fifth drug switched EU-wide through the centralized procedure.
EMA's CHMP is considering an EU-wide switch of premature ejaculation drug Fortacin, with applicant Recordati eyeing a January 2021 launch for the OTC treatment.