Sabril advisory committee postponed

Executive Summary

FDA postpones two-day advisory committee meeting on Ovation's Sabril "due to difficulties in empanelling the necessary experts due to both scheduling conflicts and conflict-of-interest." The Peripheral and Central Nervous System Drugs Advisory Committee was scheduled to meet Aug. 6-7 to review vigabatrin as adjunctive therapy for the treatment of refractory complex partial seizures in adults and treatment of infantile spasms (1"The Pink Sheet," July 14, 2008, In Brief). Ovation expects to receive an "approvable" letter in late August, followed by a final decision by the end of the fourth quarter