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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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