GSK AND POZEN ANNOUNCE TREXIMA NDA ACCEPTANCE

GlaxoSmithKline (GSK) and Pozen have announced that their new drug application (NDA) for Trexima has been accepted for review by the FDA. Trexima is the proposed brand name for the combination of sumatriptan succinate and naproxen sodium for the acute treatment of migraine. The NDA, seeking marketing approval in the U.S, was submitted in August. Pending FDA approval, the product could be available to patients as early as the second of half 2006.