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FDA postpones panel to discuss Sabril NDAs
July 23, 2008 1:08 AM UTC
FDA announced Tuesday the postponement of a Peripheral and Central Nervous System Drugs Advisory Committee meeting that was scheduled for Aug. 6-7 to discuss two NDAs from Ovation (Deerfield, Ill.) for Sabril vigabatrin. The agency said the postponement was due to difficulties in convening the necessary experts due to both scheduling conflicts and conflict of interest issues. The applications for the irreversible inhibitor of GABA-transaminase are for use as an adjunct to treat refractory complex partial seizures in adults; and to treat infantile spasms. ...