US FDA cancels panel review for Ovation's Sabril
This article was originally published in Scrip
The US FDAhas cancelled the August 6th-7th advisory panel review of Ovation's epilepsy drug Sabril (vigabatrin) because of difficulties empanelling the necessary experts owing to scheduling problems and conflicts of interest. The peripheral and central nervous system drugs panel was to consider the use of vigabatrin in two indications under priority review – adjunctive therapy for refractory partial seizures in adults and infantile spasms. Ovation previously said it anticipates receiving an action letter by the end of August and a final decision in the fourth quarter.
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