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EMA Approves EU-Wide Rx-to-OTC Switch Of Fortacin

Executive Summary

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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EU-Wide Switch Of Premature Ejaculation Drug A Real Prospect

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.

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. 

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