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news.Eurand has announced that GlaxoSmithKline has filed a new drug application with the FDA for an orally disintegrating tablet formulation of a product co-developed with Eurand using the company's Microcaps taste-masking and AdvaTab technologies.
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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.”