New Drug Approvals

eslicarbazepine

(S)-10-Acetoxy- 10,11-dihydro- 5H-dibenz[b,f]azepine- 5-carboxamide

 

Sunovion Announces FDA Acceptance for Review of New Drug Application Resubmission for Stedesa (eslicarbazepine acetate) as a Once-Daily Adjunctive Therapy for Partial-onset Seizures in Adults with Epilepsy

MARLBOROUGH, Feb 27, 2013

Sunovion Pharmaceuticals Inc. (Sunovion) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) resubmission for Stedesa® (eslicarbazepine acetate) for use as a once-daily adjunctive therapy in the treatment of partial-onset seizures in patients 18 years and older with epilepsy. Stedesa is the proposed trade name for eslicarbazepine acetate.

“We are pleased to achieve this regulatory milestone for Stedesa, which, if approved, may offer adult patients living with epilepsy an effective, once-daily, adjunctive treatment option for managing partial-onset seizures,” said Fred Grossman, D.O., FAPA, Senior Vice President, Clinical Development and Medical Affairs at Sunovion. “Adequate seizure control of…

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