GlaxoSmithKline (GSK) has completed a bioequivalence study of the formulation in August 2007 and if approved, expects to launch the product in late 2008 in the US. Eurand is entitled to a milestone payment from GSK upon FDA acceptance for review of the NDA.
Gearoid Faherty, CEO of Eurand, said: “We are pleased that GSK continues to steadily progress this product towards commercialization and look forward to the anticipated launch in 2008.”