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news.Ovation Pharmaceuticals has said that FDA has accepted the company's new drug applications or NDA for Sabril in two types of epilepsies.
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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.
Jeffrey Aronin, Ovation’s president and CEO, said: “The FDA’s acceptance of our Sabril NDA filings is a significant milestone for the company and for this development program as we continue to advance our late-stage central nervous system pipeline.”