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Home » FDA Advisory Committee Recommends REMS for Ovation’s Epilepsy Drug
FDA Advisory Committee Recommends REMS for Ovation’s Epilepsy Drug
January 9, 2009
The FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously to recommend that the FDA approve Ovation Pharmaceuticals’ anti-epileptic drug Sabril under a risk evaluation and mitigation strategy (REMS).