GSK gets FDA complete response for Eurand drug

UK drug major GlaxoSmithKline has received a US Food and Drug Administration complete response letter for the New Drug Application for  Dutch firm Eurand's EUR-1048 orally disintegrating tablet formulation  with an undisclosed active compound, that was co-developed by the firms.  GSK has submitted its response and the FDA says its review will take 60  days.

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 USA-based Wyeth Pharmaceuticals'  Inderal (propranolol).