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See Latest ArticlesSepracor's STEDESA (Eslicarbazepine Acetate) New Drug Application Formally Accepted for Review by the FDA
Sepracor, 06/02/09
Sepracor Inc. announced that it has been notified by the U.S. Food and Drug Administration that the New Drug Application for STEDESA has been accepted for filing and is now under formal review. As previously announced, the NDA for STEDESA was submitted to the FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. The acceptance of the filing means that the FDA has made a threshold determination that the NDA is sufficiently complete to permit a substantive review.
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