The FDA approved the prescription-to-over-the-counter (OTC) switch of MiraLAX in October. The FDA also ruled that MiraLAX will have marketing exclusivity for three years before any generic OTC versions of the product can be marketed.
Schering-Plough has a portfolio of switched products including Corcidin, Afrin, Tinactin, Lotrimin, Drixoral and most recently the switch of Claritin 24-hour, non-drowsy allergy products.
MiraLAX is the first prescription-to-OTC switch in the laxative category in over 30 years. MiraLAX will be available nationally, shipping to drug stores, grocery stores, and mass merchandisers beginning in February 2007.