GLAXO WELLCOME ULTIVA APPROVAL JULY 12 FOLLOWS 10-MONTH "INTERACTIVE" FDA REVIEW OF OPIOID ANALGESIC; EDUCATION PROGRAM TO BEGIN IN MID-SEPTEMBER
Executive Summary
FDA's approval of Glaxo Wellcome's Ultiva (remifentanil) analgesic opioid was based on an "interactive" NDA review process that involved the use of data summaries for the primary review.