Germany Approves Trilogy Of Switches
Three prescription-to-OTC switches approved in Germany: Levocetirizine for oral use, diclofenac for use as a patch, and preparations containing sodium bituminosulfonate and hydrocortisone acetate.
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The holy grail of consumer health innovation, Rx-to-OTC switches, are costly and hard to pull off. So, are they worth the effort? An analysis by IQVIA of desloratadine, which was switched in Germany 2020 by Novartis subsidiary, Hexal, shows that they are, with sales of OTC desloratadine products growing 112% between 2019 and 2020.
A prescription-to-OTC switch for levocetirizine has opened the door for generic producers such as Sandoz’ Hexal to extend their consumer healthcare allergy offerings in Germany.
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.