Eisai's Rufinamide Estimated User Fee Deadline Is July 2006
This article was originally published in The Pink Sheet Daily
Executive Summary
The company submitted its NDA for the anti-epileptic on Sept. 9 for the orphan indication of adjunctive therapy for Lennox-Gastaut syndrome and for adjunctive therapy for partial-onset seizures.
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Eisai Rufinamide Electronic Resubmission Aims To Make NDA More Accessible
Firm's Nov. 16 filing addresses formatting issues that led to voluntary withdrawal earlier this month of initial NDA for the anti-epileptic and sets September 2006 PDUFA date.
Eisai Rufinamide Electronic Resubmission Aims To Make NDA More Accessible
Firm's Nov. 16 filing addresses formatting issues that led to voluntary withdrawal earlier this month of initial NDA for the anti-epileptic and sets September 2006 PDUFA date.
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