FDA Accepts For Review OVATION’s Two NDA Submissions For Sabril(R)

OVATION Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s new drug applications (NDA) for Sabril® (vigabatrin) in two types of epilepsies. The FDA assigned a priority NDA review for Sabril for the treatment of Infantile Spasms (IS), and will review the submission for refractory complex partial seizures (CPS) in the same time frame.

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Filed under: Epilepsy on March 3rd, 2008