May 4 2010
Sepracor Inc., a U.S. subsidiary of Dainippon Sumitomo Pharma Co., Ltd. (DSP), today announced that the U.S. Food and Drug Administration (FDA, or Agency) has issued a Complete Response Letter to Sepracor's New Drug Application (NDA) for its antiepileptic drug candidate, STEDESA™, which is the company's proposed trade name for eslicarbazepine acetate.
“While we are disappointed by this decision, we are committed to working closely with the FDA to gain approval of STEDESA, which we continue to believe has significant potential to address the continuing unmet need in the treatment of patients with epilepsy”
The FDA issued a Complete Response Letter to the STEDESA NDA indicating that its initial review of the NDA is complete but that the Agency will not approve the application at this time. Sepracor will meet with the FDA to discuss the Complete Response Letter.
"While we are disappointed by this decision, we are committed to working closely with the FDA to gain approval of STEDESA, which we continue to believe has significant potential to address the continuing unmet need in the treatment of patients with epilepsy," said Saburo Hamanaka, Chairman and Chief Executive Office of Sepracor.
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