US FDA reschedules panel review of Ovation's vigabatrin
This article was originally published in Scrip
The US FDA's peripheral and central nervous system drugs advisory panel will meet on January 7th-8th to discuss Ovation Pharmaceuticals' NDAs for the epilepsy treatment vigabatrin. On the first day the committee will review an indication for adjunctive therapy in treating refractory complex partial seizures in adults. Vigabatrin's use in treating infantile spasms will be discussed the following day. Both indications are undergoing a priority review. The FDA cancelled a panel review originally scheduled for August because it had difficulty finding the necessary experts owing to scheduling problems and conflicts of interest. The drug is marketed for epilepsy in more than 50 countries but has been associated with visual field defects.
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