Eurand NV, a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary drug formulation technologies, has been advised by GlaxoSmithKline (GSK) that the US Food and Drug Administration (FDA) has issued a Complete Response letter for the New Drug Application (NDA) for EUR-1048. EUR-1048 is an orally disintegrating tablet (ODT) formulation with an undisclosed active compound co-developed by Eurand and GSK.

GSK also has informed Eurand that it submitted its response to the Complete Response letter on December 24th and anticipates that the FDA will take up to 60 days to review the response and take action on the NDA.

Separately, the FDA also has advised GSK that the review of another collaborative product, EUR-1000, has been extended into 2009. EUR-1000 is an AB-rated generic equivalent to Inderal LA.