Round two for Ovation’s Sabril

Executive Summary

FDA's advisory committee meeting for Ovation's GABA-transaminase inhibitor Sabril (vigabatrin) has been rescheduled for Jan. 7-8. The Peripheral and Central Nervous System Drugs Advisory Committee's review for two separate NDAs - one for adjunctive therapy for the treatment of refractory complex partial seizures in adults and one for treatment of infantile spasms - was originally scheduled for early August 2008 (1"The Pink Sheet," July 14, 2008, In Brief). The meeting was postponed after FDA was unable to find a pediatric neurologist to sit on the committee to replace Dartmouth Medical School's Greg Holmes, who was disqualified due to a conflict of interest. The conflict of interest issue caused FDA to miss the June 27 user fee date for both indications