Sabril panel rescheduled

FDA's Peripheral and Central Nervous System Drugs Advisory Committee will meet on Jan. 7-8 to discuss two NDAs from Ovation (Deerfield, Ill.) for Sabril vigabatrin. The applications for the irreversible inhibitor of GABA-transaminase are for treating infantile spasms and for use as an adjunct to treat refractory complex partial seizures in adults. In July, FDA postponed a meeting scheduled for August because of difficulties in convening the necessary experts due to both scheduling conflicts and conflict of interest issues (See BioCentury, July 28, 2008). ...