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.
Delivering only four prescription-to-OTC re-classifications in the last decade, the European Union’s (EU’s) centralized switch procedure is viewed by some as a failure.
Having only approved only four switches – GlaxoSmithKline PLC’s Alli (orlistat) weight-loss drug in 2008, Novartis AG’s Pantoloc...