EU-Wide Switch Of Premature Ejaculation Drug A Real Prospect
Executive Summary
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.
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Fortacin: EMA Recommends Fifth EU-Wide Rx-to-OTC Switch
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.
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.
EMA Reviewing Two Centralised Switch Applications
Teva's Ratiopharm and Italy's Recordati have submitted applications to switch drugs from prescription-to-OTC status through EMA's centralised procedure. Given only four products have been switched centrally to date, a double reclassification would be unprecedented.