Poland Kick Starts 2019 With Three Rx-To-OTC Switches
Clotrimazole, pyrantel, and ciclopirox olamine have been switched from prescription-to-OTC status by Poland's national drug regulator.
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Poland's drug regulator, URPL, has switched Bayer's Canesten vaginal yeast infection treatment from prescription-to-OTC status. It is the regulator's fourth switch in 2019 alone.
Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.
Trend of pharmacy closures in 2018 threatens Polish consumers' access to consumer health products, insists local OTC association PASMI. Over 90% of OTC sales in Poland currently go through pharmacies.