The FDA issued a complete response letter the STEDESA NDA indicating that its initial review of the NDA is complete, but that the agency does not approve the application at this time. Sepracor will work with the FDA the the Complete Response Letter. ‘While we are disappointed with this decision, we have to work closely with the FDA for approval of STEDESA, which we believe committed continue to win significant potential the the continuing unmet need in the treatment of patients with epilepsy ‘said Saburo Hamanaka, Chairman and Chief Executive Officer of Sepracor. A privately heldSTEDESA clinical development program.
Has Food and Drug Administration gave a Complete response Letter to Sepracor ‘s New Drug Application for its antiepileptic candidate STEDESA , which is the Company’s proposed trade name for eslicarbazepine acetate.
STEDESA been in three phase III, multicenter, randomized, placebo – controlled studies that examined more than 1,000 patients from 23 countries. Patients involved in the study had a history of at least four partial seizures per month and no seizure-free period of more than 21 days despite treatment with 1-3 concomitant AEDs.Terms of Service. This history is copyrighted If reproducing any material on, including excerpts from interviews, attribution for the Health Behavior. Newsservice, part of the Center for Advancing health care, is required. Budnitz DS, Lovegrove MC, AI Crosby emergency treatment for overdose paracetamol – containing products American Journal Prev Med 40 .
To appreciate The trial two years of data of the National Electronic Injury Surveillance System analyzed more than the annual ED visiting Germany the real sampled 63 U.S. Hospitals and findings about second Seven hundred seventeen cases left.