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Vigabatrin slated for advisory committee

Executive Summary

Ovation's Sabril (vigabatrin) is going before FDA's Peripheral and Central Nervous System Drugs Advisory Committee for two epilepsy indications. GABA-transaminase inhibitor, which has a long 34-year history, will be reviewed Aug. 6-7 in Silver Spring, Md. Ovation is seeking approval for two indications, as adjunctive therapy for the treatment of refractory complex partial seizures in adults and treatment of infantile spasms. The firm said FDA had accepted the two NDAs for Sabril and granted priority review for the infantile indication in February. Ovation says now that it expects final approval by the end of the fourth quarter. The delay is nominal given that vigabatrin was originally deemed "approvable" by FDA in 1997 for adult seizures; the product was then owned by Aventis (now Sanofi-Aventis). One safety issue likely to be raised by the panel is a peripheral visual field defect

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