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Neurology Canada Regulation

Sepracor's Stedesa gets US FDA complete response letter

This article was originally published in Scrip

Executive Summary

The US FDA has hit Sepracor (a US subsidiary of Dainippoin Sumitomo Pharma) with a complete response letter for its new drug application for the once-daily anti-epileptic Stedesa (eslicarbazepine acetate) saying that it will not yet approve it. The drug has been filed as a once-daily adjunctive therapy, in doses of 800mg and 1,200mg, for the maintenance treatment of partial onset seizures in adults.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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