Sunovion Pharmaceuticals Inc. Release: STEDESA™ Clinical Data Presented at 2011 American Epilepsy Society Annual Meeting
12/2/2011 9:12:46 AM
MARLBOROUGH, Mass.--(BUSINESS WIRE)--Sunovion Pharmaceuticals Inc. (Sunovion) announced today that the company has finalized its plans for resubmitting the New Drug Application (NDA) for STEDESA™ (eslicarbazepine acetate [ESL]) to the U.S. Food and Drug Administration (FDA). Sunovion received a Complete Response Letter from the FDA in April 2010, and since then has identified a path forward for the NDA resubmission. Results of an ongoing clinical trial are expected to be available in the second quarter of 2012, and will be included in the STEDESA NDA resubmission.