FDA decision on ProStrakan's Sancuso expected in week of June 7

Scottish drugmaker ProStrakan says there are now no outstanding technical questions from the US Food and Drug Administration's review of Sancuso (transdermal granisetron patch) for the prevention of chemotherapy-induced nausea and vomiting other than those which will be dealt with in labeling negotiations. The company is also issuing an updated timeline for completion of the remaining review process. ProStrakan submitted a New Drug Application for Sancuso to the FDA in June 2007. The regulator originally assigned an action date of May 2 but, due to internal resource constraints within the agency, this date was amended to June 10. It is clear, however, that the remaining processes and procedural steps cannot be completed by this date, the firm stated, adding that completion was expected by the week of June 7.