Previously available by prescription, MiraLAX (polyethylene glycol 3350 or PEG 3350) became an over-the-counter (OTC) treatment for occasional constipation in early 2007. Due to FDA policy which does not allow the same formulation of a product to be marketed simultaneously as both a prescription and OTC drug, generic PEG 3350 products are now also becoming unavailable by prescription.
These generic products will not be available on the OTC market for at least three years following the MiraLAX introduction due to marketing exclusivity granted by the FDA.
A J Kazimi, CEO of Cumberland, said: “Kristalose has a long history of providing safe and effective relief to sufferers of acute and chronic constipation with few side effects. We look forward to communicating the unique features of this drug to the medical community and ultimately to patients who may benefit from it.”